JOURNAL OF MEDICINAL FOOD

J Med Food 13 (3) 2010, 650–656

# Mary Ann Liebert, Inc. and Korean Society of Food Science and Nutrition
DOI: 10.1089=jmf.2009.0171

The Lipid-Lowering Effects of 4 Weeks of Daily Soymilk or Dairy Milk Ingestion

in a Postmenopausal Female Population
Kristen M. Beavers,1 Monica C. Serra,1 Daniel P. Beavers,2 Geoffrey M. Hudson,1 and Darryn S. Willoughby1
Departments of 1Health, Human Performance, and Recreation and 2Statistics, Baylor University, Waco, Texas, USA

ABSTRACT Alterations in plasma cholesterol concentrations, especially increases in low-density lipoprotein (LDL), are
well-known risk factors in the development of atherosclerosis. Numerous studies have examined the lipid-lowering effects of
functional soy-containing foods, but few have specifically examined soymilk, with equivocal findings reported. In September
2008, a single-blind, randomized, controlled trial was conducted on 32 postmenopausal women at Baylor University, Waco,
TX, USA. After a 2-week run-in period, subjects were randomly assigned to consume three servings of vanilla soy (n ¼ 16) or
reduced-fat dairy (n ¼ 16) milk per day for 4 weeks. Plasma lipid profiles were obtained pre- and post-supplementation.
Plasma high-density lipoprotein, LDL, and triglycerides were not significantly different between groups post-intervention
(P ¼ .45) or from baseline (P ¼ .83). Separate analysis of plasma total cholesterol levels yielded similar results (P ¼ .19 and
P ¼ .92, respectively). Furthermore, subanalyses controlling for dyslipidemia (n ¼ 23) and lipid-lowering medication usage
(n ¼ 28) did not significantly alter results. Despite good dietary compliance, our study failed to show a significant hy-
pocholesterolemic effect of soymilk consumption in this postmenopausal female population. Potential reasons for this non-
significant finding are discussed, and future research directions are presented.

KEY WORDS:
cardiovascular disease
cholesterol
isoflavones
lipid lowering
soy

INTRODUCTION derson et al.,7 which showed that an average intake of 47 g of

soy protein=day resulted in a 9% decrease in total cholesterol
C ardiovascular disease (CVD) is the leading cause of
death in the United States, affecting one in three adults.1
Atherosclerosis is the process by which CVD occurs, and
(TC), 13% decrease in LDL, 10% decrease in triglyceride
(TG), and a moderate 2.4% increase in high-density lipo-
protein (HDL). More recent studies6 suggest that the bene-
alterations in plasma cholesterol concentrations, especially
ficial effect of soy protein on cholesterol may be more modest
increases in low density lipoprotein (LDL), are well-known
than originally proposed; however, over a period of many
risk factors in the development of the disease.2 Furthermore,
years even a modest improvement in blood lipids levels has
blood cholesterol values are negatively associated with es-
the potential to decrease coronary heart disease risk.
tradiol and have been shown to increase in women who are
With regard to isoflavones, current research indicates that
postmenopausal.3 Because of the relatively low incidence of
when consumption of soy protein-containing isoflavones
CVD found in Asian countries, researchers in the late 1960s
is compared to that of isoflavone-depleted soy protein, lipid
began to exam the cardiovascular benefit of consuming a diet
profiles are significantly improved.5,9 Results from a recent
high in soyfoods, as soy is a staple of Asian cuisine. Since
meta-analysis6 suggest that soy protein coupled with at least
then, more than 100 clinical studies have explored the effects
40 mg=day isoflavones has lipid-lowering effects and that
of soy protein on blood cholesterol levels.4–7
such effects are magnified when ingestion increases to
The exact mechanism by which soy lowers blood lipids
80 mg=day. Interestingly, these beneficial results may not
remains unclear, but in 1999 the Food and Drug Adminis-
apply to isoflavone intake alone. In a study examining the
tration approved a health claim stating that the inclusion of
effects of 6 weeks of isolated isoflavone intake (90 mg=day
soy protein into a diet low in saturated fat and cholesterol may
vs. placebo) on cardiovascular risk factors in moderately
reduce the risk of coronary heart disease by lowering blood
hypercholesterolemic, postmenopausal women,10 the authors
cholesterol levels.8 This claim was substantiated in numerous
found that while both groups experienced small reductions
clinical trials, including the seminal meta-analysis by An-
in total and LDL cholesterol, this decrease was not statisti-
cally significant, and no difference was noted between
Manuscript received 13 May 2009. Revision accepted 22 August 2009. groups. Therefore, in light of recent research, it appears that
supplementing a combination of soy protein with apprecia-
Address correspondence to: Kristen M. Beavers, Ph.D., R.D., Department of Health,
Human Performance, and Recreation, Baylor University, One Bear Place # 97304,
ble amounts of isoflavones may yield the most favorable
Waco, TX 76798-7313, USA, E-mail: kristen_beavers@baylor.edu lipid-lowering effect.

650
 SOYMILK AND LIPID LOWERING
Unfortunately, many of the clinical studies addressing the
lipid-lowering potential of soy often fail to incorporate
commercially available soyfoods, such as soymilk. Because
it is plausible that synergistic effects may exist among iso-
lated soy constituents, there is considerable need for studies
examining whole soyfood consumption. To date, only a few
studies have specifically examined the lipid-lowering ben-
efits of soymilk consumption,11–15 and the results of these
studies have been equivocal. Due to the lack of consensus in
the literature, as well as the current reevaluation of the
support for the Food and Drug Administration health claim,
the purpose of this study was to examine the effects of
soymilk consumption on plasma lipid levels in a postmen-
opausal female population.
MATERIALS AND METHODS
Primary and secondary outcomes
This analysis was a part of a trial originally designed to
examine the ability of soymilk to attenuate exercise induced
inflammation and oxidative stress. The primary outcome of
this substudy was to examine the lipid-mediating properties
of soymilk. We hypothesized that participants randomized
to consume three servings of soymilk per day for 4 weeks
would have statistically greater reductions in traditional
markers of cholesterol than the control (dairy) group. Spe-
cifically, we examined plasma levels of TG, TC, LDL, and
HDL in the entire group of participants post-intervention.
Secondary outcomes included the change in the aforemen-
tioned cholesterol values over the supplementation period
and two subanalyses of the dataset controlling for select
confounders. Because of concerns that lipid-lowering
medications may affect study results, we performed a sub-
analysis omitting study participants who reported current
use of any prescription lipid-lowering or lipid-controlling
medication. Additionally, subanalysis of the individuals
with dyslipidemia, as defined by the National Cholesterol
Education Program Adult Treatment Panel III criteria16 in at
least one of the lipid markers measured was also conducted
to determine if baseline cholesterol status impacted treat-
ment efficacy.
Participants
Thirty-two apparently healthy, recreationally active,
postmenopausal women between the ages of 40 and 60 years
were used as participants in the study. A power calculation
revealed that 16 participants per group were necessary to
detect a significant difference between groups in markers of
lipid lowering (LDL effect size of 20 mg=dL11) given a
Type I error rate of 0.05, SD of 19 mg=dL, and a power of
0.80. Participants were recruited from the Central Texas
area and were considered eligible to participate in the study
if they were physically active but not trained (not engaged in
an exercise program involving either resistance or endur-
ance training more than three times per week for 1 year) and
postmenopausal (naturally or surgically amenorrheic >1
year prior to start of study) and could adhere to the study
651
protocol. Exclusionary criteria included active use of hor-
mone replacement therapy, presence of coronary artery
diseases and=or other significant uncontrolled cardiovascu-
lar, renal, hepatic, gastrointestinal, mental, and endocrine
disorders including diabetes mellitus, a body mass index of
<19 kg=m2 or >35 kg=m2, active smoking status (within the
past 3 years), an average intake of more than two alcoholic
drinks per day, and=or the consumption of any dietary
supplements that could affect antioxidant status (excluding
multivitamins) 3 months prior to beginning the study. All
eligible subjects were required to obtain medical clearance
from their personal physician and sign Baylor University
(Waco, TX, USA)-approved informed consent documents.
Study design
This study was conducted as a 4-week single-blind, ran-
domized, controlled trial. Prior to randomization, the pro-
tocol included a 2-week run-in phase in which participants
met with a registered dietitian and were educated and in-
structed to limit the amount of dairy products consumed
(avoid dairy milk completely and limit dairy servings to two
per day) and to avoid isoflavone-containing soy products.
This was done in attempt to minimize baseline dietary dif-
ferences between groups with regard to dietary treatments.
At this time, participants also provided a 24-hour baseline
dietary recall to the registered dietitian so that baseline
protein intake could be assessed using the Food Processor
Dietary Assessment Software program (ESHA Research
Inc., Salem, OR, USA).
After the run-in phase, participants were then scheduled
to report to the Exercise & Sport Nutrition Laboratory at
Baylor University for baseline testing. This testing session
included personal and medical questionnaires, height and
weight measurements, blood sampling, dietary intake as-
sessment, and aerobic fitness (maximal oxygen uptake
[VO2 max]) testing by performing a cardiopulmonary graded
exercise test on a treadmill ergometer (Quinton, Inc., Bo-
thell, WA, USA). After the testing session, participants were
matched based on baseline protein intake and cardiopul-
monary fitness level, as both have been shown to affect
circulating blood lipids,7,17,18 and were randomly assigned
to consume three servings of either soymilk or dairy milk
per day for 28 days. The milk was provided to the partici-
pants in black bags labeled ‘‘A’’ or ‘‘B’’ in such a way that
investigators were blinded to treatment order. Participants
were instructed to return to the Exercise & Sport Nutrition
Laboratory 2 weeks into the supplementation period, to pick
up additional milk, and again at 4 weeks, for follow-up
testing including the same battery of tests performed at base-
line with the exception of the aerobic fitness test.
Milk products
Both milk products were provided by WhiteWave Foods,
Inc. (Broomfield, CO, USA). The soy product was the SilkÒ
brand very vanilla flavored soymilk, and the dairy product
was the HorizonÒ brand reduced-fat organic dairy milk. The
commercial beverages were matched as closely as possible
652 BEAVERS ET AL.

for fluid volume, total caloric, and macronutrient intake. assess the adequacy of our randomization scheme. Study
Nutrient profiles of the milk beverages obtained from the compliance, defined as the percentage of prescribed bever-
nutrition facts panel are shown in Table 1. Because the milk age consumed, was assessed across groups using a two-
products were not matched based upon dietary fat or cho- sample Wilcoxon rank-sum test as these data were
lesterol intake and because slight alterations in macro- and demonstrably non-normal.
micronutrient intake were likely over the 4-week supple- We analyzed the reported dietary intake variables to
mentation period (despite instructions to maintain a similar evaluate the potential confounding effects of certain nutri-
diet to baseline), equations were used to predict changes in tional variables known to interact with plasma lipid levels.
TC19 and LDL.20 The prediction equations used dietary We then compared means across groups at baseline using
intake of saturated and polyunsaturated fat and cholesterol univariate t tests, and, using repeated-measures analyses of
to predict changes in plasma cholesterol values. variance on each variable, we assessed the effect of the
time=intervention on the dietary intake.
Dietary intake Group-specific means were compared for the primary
study outcome for the full analysis and subgroup analyses
To assess dietary intake, each participant was asked to
using a multivariate analysis of variance. The outcome of
keep 4-day dietary records at baseline and during the second
within-individual change from baseline was assessed using a
half of the 4-week supplementation period. The dietary re-
repeated-measures analysis of variance; specifically of in-
cords were then analyzed using the Food Processor Dietary
terest is whether a grouptime interaction was statistically
Assessment Software program. In an attempt to determine
significant. We then repeated these analyses using the uni-
compliance with the milk supplementation protocol, each
variate outcome of plasma TC and the change in plasma TC
participant was instructed to keep a compliance log of daily
from baseline. All numerical summaries and statistical
milk ingestion to be submitted to investigators at the 4-week
comparisons were conducted using SAS version 9.1.3 (SAS
testing session. Authors of similar studies21,22 have sugges-
Institute, Cary, NC, USA), and the Type I error rate (a) was
ted the standard of compliance is between 80% and 100%;
held constant at 0.05 for all tests.
thus, a threshold of <80% consumption of the prescribed
supplement was defined as ‘‘non-compliant’’ a priori. Fi-
RESULTS
nally, a reported side effects questionnaire was administered
at baseline and at 2 and 4 weeks to determine if any sig- Study population
nificant negative side effects occurred during the course of
the study because of the dietary supplementation. Recruitment for this study began September 2008, and
participant testing ended December 2008. A total of 33 in-
Plasma lipid assessment dividuals who met entrance criteria were recruited to begin
the study. Baseline blood work for one participant was un-
Fasting venous blood samples were obtained before and able to be collected because of an early non-intervention-
after the supplementation period from the antecubital vein related dropout, leaving 32 participants retained for
into a 10-mL collection tube using a standard VacutainerÔ analysis. Baseline demographics for the 32 individuals who
apparatus (BD, Franklin Lakes, NJ, USA). Blood samples completed the study are found in Table 2. No statistically
were allowed to stand at room temperature for 10 minutes significant differences were observed in any of these vari-
and then centrifuged. For each sample, the plasma was re- ables between treatment groups. Additionally, no significant
moved and frozen at 808C for later analysis. Plasma HDL, weight changes were observed during the course of the in-
LDL, TG, and TC levels were then assessed by a trained tervention (P ¼ .25).
technician using the Dimension RxL Clinical Chemistry
System (DADE Behring Inc., Deerfield, IL, USA).
Table 2. Baseline Demographic Statistics Including Plasma
Statistical analysis Lipid Values by Treatment Group
Baseline demographic, health, and dietary characteristics Vanilla soymilk Reduced-fat
were summarized as sample mean and SD values. Means group dairy milk
between groups were compared using independent t tests to (n ¼ 16) group (n ¼ 16)
Age (years) 53.88  3.65 54.87  3.05
BMI (kg=m2) 25.36  4.05 26.30  3.82
Table 1. Nutrient Profile of One Serving of the Milk Cardiopulmonary 25.60  4.86 25.57  4.70
Supplements Provided to Study Participants fitness (VO2 max)
Baseline fasting lipid
Vanilla soymilk Reduced-fat
values (mg=dL)
(8.25 fl oz) dairy milk (8 fl oz)
TC 191.50  28.79 208.13  23.56
Calories (kcal) 130 120 TG 103.50  79.35 113.25  82.63
Fat (g) 4 4.5 LDL 106.56  24.22 115.62  20.21
Protein (g) 6 8 HDL 63.06  12.01 66.81  17.21
Carbohydrates (g) 19 12
Data are mean  SD values.
 SOYMILK AND LIPID LOWERING
Dietary compliance
According to a Wilcoxon-rank sum test, there was no
statistically significant difference in compliance between the
treatment groups (P ¼ .35). Although compliance logs are
often unreliable indicators of dietary adherence, results from
4-day food records analyzed post-intervention also support
this conclusion. A per-protocol compliance threshold was
defined as >80% supplement consumption, and only one
participant was defined as non-compliant. Removing this
participant from analysis yielded average compliance rate of
98% across both groups. Analysis excluding this individual
from the data set revealed no significant differences with
regard to the primary outcome measures; therefore, only
intention-to-treat analysis is presented. Reported side effects
questionnaires administered at baseline and at 2 and 4 weeks
also revealed minimal and equivocal side effects between
treatment groups.
Dietary intake
Dietary intake data are presented in Table 3. No differ-
ences were observed in any of the dietary variables by group
prior to supplementation. A time effect across both groups
was observed for kilocalories (P ¼ .02), protein (P < .01),
fat (P ¼ .02), and saturated fat (P < .01), with all values
increasing over the course of the intervention. Although
discrepancies did exist in the supplement nutrient profiles,
dietary intake analysis did not reveal statistically significant
caloric or macronutrient differences between groups post-
intervention. Saturated fat values were found to be elevated
in the dairy group overall (P ¼ .05), and a significant
grouptime interaction was noted for fiber (P < .01) and
cholesterol (P ¼ .02).
According to the predictive equation by Keys,19 the pre-
dicted change in TC was an overall increase in both the
soy and dairy groups, with no significant difference ob-
served between groups (2.54  0.28 vs. 1.73  0.32 mg=dL,
Table 3. Main Food Components Consumed During the Study by Treatment Group
According to 4-Day Food Record Analysis
Vanilla soymilk group (n ¼ 16)
Pre-intervention Post-intervention
Calories (kcal=day) 1,582.01  365.75 1,769.73  364.82a
Carbohydrates (g=day) 184.03  56.03
Protein (g=day) 75.44  25.41
Fat (g=day) 61.07  20.40
Saturated fat (g=day) 16.38  6.29
Monounsaturated fat (g=day) 14.90  6.54
Polyunsaturated fat (g=day) 9.72  9.77
Cholesterol (mg=day)c 214.96  112.72
Fiber (g=day)c 17.46  4.59
Data are mean  SD values.
aDenotes significant differences from baseline (P < .05).
bDenotes a significant group effect (P < .05).
cDenotes significant grouptime interaction (P < .05).
653
respectively; P ¼ .61). Based on the equation of Hegsted
et al.,20 the predicted change in LDL was significantly dif-
ferent between the soy and dairy groups, with the soy group
having a projected decrease versus a projected increase
in the dairy group (-1.51  0.24 vs. 1.65  0.26 mg=dL, re-
spectively; P ¼ .02).
Plasma lipid outcomes
Figure 1 displays final plasma lipid markers post-
intervention by treatment group. No statistically significant
differences were observed between groups (soy vs. dairy)
with regard to TG (105.94  72.79 vs. 112.38 
62.79 mg=dL), LDL (111.44  30.38 vs. 122.56  33.48 mg=
dL), or HDL (62.69  13.29 vs. 68.13  15.32 mg=dL) val-
ues post-intervention (P ¼ .45). Likewise, no changes were
observed from baseline (P ¼ .83). Because total plasma TC
is a linear combination of LDL, HDL, and other lipid
components, it was assessed separately. No changes were
observed post-intervention (195.88  35.28 vs. 213.50 
40.50 mg=dL; P ¼ .19) or from baseline (P ¼ .92).
To preserve the original randomization scheme, partici-
pants reporting active use of cholesterol-lowering medica-
tion were retained for the initial analysis. However, because
of the potential for confounding, a subanalysis was per-
formed excluding four participants who reported use of
cholesterol-lowering medications on medical history ques-
tionnaires (n ¼ 28). Such an analysis did not significantly
alter the change in lipid values from baseline (TG, LDL, and
HDL, P ¼ .69; TC, P ¼ .97) or post-intervention between
groups (TG, LDL, and HDL, P ¼ .68; TC, P ¼ .41). Addi-
tional subanalysis of those individuals with dyslipidemia
(n ¼ 23) did not reveal any significant changes in TG,
LDL, or HDL from baseline (P ¼ .92) or post-intervention
between groups (P ¼ .74). Likewise, TC remained un-
changed (P ¼ .95 change from baseline and P ¼ .57 post-
intervention).
Reduced-fat dairy milk group (n ¼ 16)
Pre-intervention Post-intervention
1,685.68  394.96 1,827.71  520.11a
208.89  55.19 207.53  50.79 216.48  67.21
94.66  22.70a 65.39  16.74 90.89  22.46a
67.30  22.97a 63.37  22.25 77.26  25.42a
20.39  13.56a 19.95  7.85b 28.27  8.68ab
16.76  8.51 16.18  9.26 20.06  9.10
13.47  5.66 9.02  6.26 8.72  5.77
168.36  97.38 225.74  148.78 291.56  105.15
26.70  4.68 16.35  6.52 15.98  6.00
654 BEAVERS ET AL.
300.00
250.00
200.00
mg/dL
150.00
100.00
50.00
0.00
HDL LDL TG
Plasma Lipid Levels
DISCUSSION
In this 4-week intervention study, we failed to find a sig-
nificant hypocholesterolemic effect of soymilk consumption
in a postmenopausal female population, despite good re-
ported compliance with the dietary protocol. Although
discussion of the plausible factors contributing to this non-
significant result is warranted, it is first prudent to reflect on
these findings in the context of related clinical trials.
Several studies have shown that soymilk consumption is
associated with a reduction in plasma lipid levels, especially
in hypercholesterolemic patients. Gardner et al.11 enrolled
28 hypercholesterolemic men and women in a crossover
study comparing the lipid-lowering responses to two com-
mercially available soymilks (one with appreciable amounts
of isoflavones [125  17 mg=day] and one without (39 
1 mg=day]) with low-fat dairy milk. After 4 weeks of in-
tervention, results showed that consumption of soymilk was
associated with a modest reduction in LDL cholesterol
compared to low-fat dairy milk, regardless of isoflavone con-
tent. Interestingly, results from a previous study of similar
design23 suggest that the isoflavone-containing fraction is
an important factor in the lipid-lowering properties of soy
products, with the authors reporting a significant increase
in the total and LDL cholesterol-lowering ability of a soy
protein plus isoflavone beverage compared to a beverage
prepared solely with isolated soy protein.
Two other studies worthy of note also examined the
lipid-lowering potential of soymilk consumption in hy-
percholesterolemic patients.12,13 Bricarello et al.12 re-
cruited 60 hypercholesterolemic men and women, between
the ages of 20 and 70 years, to consume either soy or nonfat
dairy milk at 1 L=day for 6 weeks. No effect of soymilk
was observed for TC and TG, but soymilk consumption
reduced plasma LDL cholesterol and increased HDL cho-
lesterol compared to baseline and the dairy milk group.
Conversely, when 16 hypercholesterolemic men and
women participated in a crossover study in which diets
were supplemented with either 500 ml=day dairy or high-
glycitein soymilk for 4 weeks, no statistical differences
from baseline and between dietary groups was observed for
any cholesterol values.13
FIG. 1. Final plasma lipid markers
Soy after 4 weeks of milk supplementation
Dairy by treatment group.
TC
Lastly, in a randomized trial that compared the effects
of soy proteins from differently processed products with
animal protein on a variety of CVD risk factors,14 no dif-
ference was observed between groups in any of the car-
diovascular outcomes assessed. Furthermore, a separate
analysis of the soymilk-based diet (i.e., included plain
soymilk, plain soy yogurt, and tofu) revealed a signifi-
cantly greater lipid-modulating potential (4% decrease in
LDL cholesterol) than the other experimental diets relative
to the animal-protein diet.
Given our findings and the inconsistencies in the literature
regarding the lipid-lowering potential of soyfoods, it is of
further interest to explore what factors may have contributed
to this nonsignificant result. Baseline cholesterol status,
supplement type, dosage, and duration, as well as dietary
control, are all potential confounding agents that have been
identified and are discussed below.
Baseline cholesterol status
It is recognized that the extent of cholesterol lowering by
soy may be dependent on initial plasma levels,6,7 with some
studies suggesting that definitive hypocholesterolemic ef-
fects only occur in patients with significant hypercholes-
terolemia (TC values of  270 mg=dL).7 In an attempt to
control for baseline cholesterol values, a subanalysis of our
dataset was performed, including only those individuals
with some form of dyslipidemia as defined by the National
Cholesterol Education Program Adult Treatment Panel III
criteria16 (n ¼ 23), although doing so did not significantly
alter the results. However, in our entire cohort, the highest
baseline TC level was 250 mg=dL; therefore, it is possible
that baseline plasma TC levels may not have been suffi-
ciently elevated to observe a significant reduction. Despite
this line of reasoning, it should be noted that recent results
suggest that hypocholesterolemic effects of soymilk can be
seen in normolipidemic subjects.15
Supplement dosage
Another reason for the nonsignificant finding of this study
could be due to the type and amount of soy provided.
 SOYMILK AND LIPID LOWERING
Although multiple studies have reinforced the need for
combined isoflavone and soy protein consumption to obtain
more favorable cardioprotective benefits, perhaps we did not
supply participants with enough of either or both to see a
pharmacologic effect. At present, the Food and Drug Ad-
ministraiton health claim states that consumption of 25 g
of soy protein=day is needed to see a reduction in the risk
of heart disease. In our study (assuming an average of 98%
compliance with the dietary protocol), total soy protein
consumed by the soymilk group was roughly 18 g=day.
Although more recent studies suggest that as little as 20 g of
soy protein=day can lower non-HDL cholesterol and have
favorable cardiovascular effects,24 the possibility remains
that the amount of soy protein provided in approximately 3
cups of soymilk per day was not enough to significantly
improve blood lipid levels. In terms of isoflavone content,
recent meta-analyses support the notion that intakes of soy
protein coupled with isoflavone above 40 mg=day have
lipid-lowering effects.6 Although the isoflavone content of
the soymilk used was not analyzed, Gardner et al.11 used a
similar product and showed that 3 cups of soymilk supplies
approximately 90 mg of isoflavones, although the content
per sample was noted to be highly variable. Despite this, it is
likely that our study design provided a sufficient amount of
isoflavones to potentiate a reduction in cholesterol levels.
Lastly, the possibility remains that in spite of reported die-
tary compliance, participants may not have adhered to the
study protocol, rendering intake insufficient. Unfortunately,
because of funding restraints we were unable to analyze
blood or urinary isoflavones and were dependent on par-
ticipant truthfulness in compliance reporting. We implore
the need for future studies to assess these markers with more
objective indicators of compliance as a means of process
evaluation.
Time course of administration
Although the amount of time allotted for supplementation
in our study was comparable to11 or only slightly shorter in
duration than12,13 other studies observing favorable out-
comes, our study failed to find a significant result. Results
from the meta-analysis performed by Zhan and Ho6 suggest
that the strongest lowering effects of soy protein containing
isoflavones on TC, LDL, and TG occurs within the short
initial period of intervention (6 weeks). Therefore, it is
likely that our study was of sufficient duration to see initial
improvements in these specific markers. HDL improve-
ments, however, appear to require a longer intervention
period as Zhan and Ho5 found that increases in HDL cho-
lesterol were only observed in studies of greater than 12
weeks of duration.
Dietary control
This study was conducted in free-living individuals.
Although this may have hindered protocol adherence, di-
etary and compliance analysis suggests that it did not. All
dietary variables included in this analysis were similar by
655
group at baseline, but there were significant changes in
select dietary variables at 4 weeks. The increases observed
across both groups for kilocalories, protein, fat, and satu-
rated fat across time were likely due to the intervention
itself as participants in these types of studies often do not
reduce dietary intake to account for supplemental intake.
However, while this increase could confound the plasma
lipid changes from baseline, it would not explain the lack
of difference between groups post-intervention. Conversely,
the overall increased amount of saturated fat intake observed
in the dairy group (particularly post-intervention) as well as
the grouptime interaction for fiber and cholesterol in-
take may explain the nonsignificant post-intervention find-
ings with regard to plasma lipids, although this is quite
speculative.
Attempts were made to control for dietary fat intake by
using predictive equations. No changes in TC were pro-
jected based upon dietary intake of saturated and polyun-
saturated fat and cholesterol, but it was predicted that the
soy group would have a decrease in LDL, while the dairy
group would observe an increase in LDL. Unfortunately,
these predictive equations do not incorporate other dietary
variables associated with alterations in plasma cholesterol,
such as fiber or select antioxidants. Additionally, error with
the use of predictive equations also exists. Similar to our
results, a meta-analysis examining the effects of dietary fat
on serum cholesterol found that the predicted TC and LDL
levels were significantly lower on a high polyunsaturated
diet relative to a high monounsaturated fat diet; however,
the observed lipid differences were not significant.25 Fi-
nally, it is possible that inaccuracies in using a 4-day dietary
record to assess food intake confounded our results. Dietary
records are considered accurate for estimating stable dietary
components, such as total kilocalories and percentage of
macronutrients, but more variable nutrients such as dietary
cholesterol may require 2–3 weeks of recording to accu-
rately estimate intake.26
CONCLUSIONS
In light of increasing use, it is important to understand the
health effects of soymilk. Although numerous studies have
reinforced the need for combined isoflavones and soy pro-
tein consumption to obtain favorable cardioprotective ben-
efits, our study failed to show an improvement in the lipid
profile. Future research should seek to clarify the biological
mechanism responsible for the lipid-lowering benefit of
soyfoods, as well as the importance of study population
characteristics, intervention type, dosage, and time course of
soyfood consumption necessary to achieve a significant im-
provement in lipid profiles.
ACKNOWLEDGMENT
We would like to thank Dr. Mark J. Messina for
thoughtfully reviewing this manuscript and significantly
contributing to its completion.
656 BEAVERS ET AL.
AUTHOR DISCLOSURE STATEMENT
The authors have no relevant financial relationships to
disclose. Funding for this study was provided by White-
Wave Foods, Inc. (Broomfield, CO, USA).
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