Digestive Formula

Healthcare Professional Product Guide

This is an educational publication provided to
help licensed healthcare professionals understand
the science upon which Digestive Formula is
based and its nutrient content mechanisms of
action in the body.This guide should not be used
to sell Digestive Formula and is intended for
healthcare professionals only.
The only claims that can be made for
Digestive Formula are those that have been
approved by the Company.

A Scientific Product Review

Comprehensive multi-nutrient supplement for healthy digestion*
The Foundation For Proper Nutrition*

Official Sponsor of the 20002004 U.S. Olympic Team

36 USC 220506

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Digestive Formula
For Healthy Digestion*
Summary
Digestive Formula is a dietary supplement developed
and manufactured by Pharmanex, LLC that has been
formulated to provide all-natural, comprehensive
support for healthy digestion and the prevention of
occasional intestinal discomfort due to overindulgence
in food and drink.* Standardized Artichoke leaf extract,
Ginger root extract, and a proprietary plant-based
blend of enzymes offer a unique three-step approach
to healthy digestion.* Each of these ingredients may
help aid the healthy digestion of food, prevent and
alleviate symptoms of occasional indigestiongas,
bloating, and heartburn, promote food tolerance, and
help relieve the symptoms of overindulgence in food
or drink.* Digestive Formula is recommended to be
taken with meals for the relief or prevention of the
symptoms associated with occasional indigestion.*

Background
The function of the digestive tract is to break
down the foods we eat into simple molecules such as
glucose, amino acids, and fatty acids. Proper digestion
is essential for good health; anything that adversely
affects digestion may not only cause discomfort, but
may lead to more serious conditions. Millions of
people throughout the world suffer from impaired
digestion and digestive complaints. About one third
of the total US population suffers from occasional
digestive complaints.1 Symptoms include early feelings
of satiation and loss of appetite, heartburn, nausea,
vomiting, flatulence, excessive belching, fat intolerance,
irregular bowel movements, etc.2
Many digestive complaints may be due to a poorly
functioning liver-bile system.1 The liver stimulates bile
production, which is then stored in the gall bladder;
bile is secreted from the gall bladder into the small
intestine to help digest fats. Bile is also a primary route
through which toxins are eliminated from the body, so
when bile production is inhibited, this can lead to
increased retention of toxic substances.3 Furthermore,
bile promotes the incorporation of water into stools,
thus softening them.
Decreased bile flow is considered to be the main cause
of non-ulcer digestive complaints.1 Decreased bile flow
is a common cause of digestive disturbances including

constipation or diarrhea, fat malabsorption, excessive

flatulence, and bloating after meals. Experts suggest
that fat malabsorption may delay gastric emptying and
is a primary cause of indigestion. Today it is generally
accepted that an increase of bile secretion promotes
digestive comfort, and may have a positive influence
on intestinal motility. Promoting the secretion of
saliva and gastric juice may also assist in minimizing
digestive complaints.1

Primary Active Constituents

The constituents of Digestive Formula include
Artichoke (Cynara scolymus) leaf extract, Ginger
(Zingiber officinalis) root extract, and a proprietary
blend of plant-based enzymes.
Experts suggest that the observed benefits from
Artichoke leaf extract are primarily due to the presence
of caffeoylquinic acids.4 The Artichoke leaf extract
found in Digestive Formula is standardized to 15%
caffeoylquinic acids, three times the concentration of
other products currently available on the market.
Ginger root contains non-volatile pungent principles
including phenols, such as gingerols.5 The ginger root
extract found in Digestive Formula is standardized to
5% gingerols.
The proprietary Pharmanex blend of digestive
enzymes includes amylase, glucoamylase, pH-specific
proteases, bromelain, lipase, cellulase and lactase. The
enzymes found in Digestive Formula are derived
from plant-based sources.
Target Compound
Carbohydrates

Digestive Enzyme(s)
Amylase (Starch)
Glucoamylase (Maltodextrins)
Cellulase (Cellulose)
Lactase (Lactose)

Proteins

Proteases
Bromelain

Fats

Lipase

Health Benefits
Digestive Formulas unique 3-step approach stops
the symptoms of occasional indigestion before they start
by promoting healthy digestion and may help prevent
and alleviate symptoms of occasional indigestiongas,
bloating, and heartburn, and help relieve the symptoms
of overindulgence in food or drink.* 3,611

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Artichoke Leaf Extract

(15% caffeoylquinic acids)

Ginger Root Extract

(5% gingerols)

Helps ease nausea*

Promotes secretion of saliva and
gastric juice*

Proprietary Enzyme Blend

May assist the body in digesting

fats, carbohydrates, and proteins*
May improve food tolerance,
especially fatty foods, fiber-rich
foods, and dairy products*

Clinical Evidence of Efficacy

ArtichokeClinical Studies
Several double blind, placebo-controlled clinical
studies have evaluated the efficacy and safety of Artichoke extract in the treatment of digestive complaints
associated with the liver-bile system, such as upper
abdominal pain, heartburn, sensation of fullness, nausea,
and loss of appetite.4 Artichoke leaf has been approved
by the German Commission E for digestive complaints
(dyspeptic problems).15
In a study with 553 patients, the effectiveness and
tolerance of Artichoke leaf extract was evaluated. After
six weeks, the relative severity of symptoms decreased
for vomiting by 88%, sickness by 82%, abdominal pain
by 76%, constipation by 71%, flatulence by 68%, and
fat intolerance by 58%. Ninety-eight percent of the
patients rated the effectiveness of Artichoke leaf
extract better than previous therapies.12,13
Oral administration of Artichoke extract has been
shown to increase gastrointestinal propulsion, and
increase bile flow and the concentration of biliary acids
by approximately 30 40%.14 In a double-blind, placebocontrolled, randomized study, it was demonstrated that
Artichoke leaf extract significantly increased the amount
of bile secretion into the duodenum of healthy
volunteers (p<0.01).12,13 After 30 minutes, biliary
secretion increased 127%, and increased 151% after 60
minutes (see graph). In another study involving patients
with acute or chronic metabolic disorders, it was
concluded that Artichoke extract can be used for the
treatment of digestive disorders characterized by poor
assimilation of fat due to insufficient bile secretion.13,15

% Change in Biliary Secretion13

Relative change in
biliary volume [%]

Promotes the bodys production

of digestive juices*
Promotes normal bile production*
Assists the livers ability to metabolize alcohol*
Helps prevent gas, bloating, and
feeling of fullness due to indigestion
caused by overeating*

160
140
120
100
80
60
40
20
0
-20
-40

Artichoke
Leaf Extract
Placebo

30

60

90

120

150

180

Time [minutes]

GingerClinical Studies
Based on current research, Ginger has been shown
to be effective in reducing nausea of various causes.
In a double blind, placebo-controlled clinical study,
80 naval cadets were given Ginger or a placebo while
at sea. Symptoms of nausea were recorded once an
hour during 4 hours after treatment. Symptoms in the
Ginger group were 38% less than in the placebo group.16
Another clinical study evaluated the efficacy of Ginger
in 36 patients with histories of severe motion sickness.
The Ginger group was able to tolerate mechanically
induced motion sickness better than the dimenhydrinatemedicated group and the placebo group.17
The effectiveness of ginger in post-surgery nausea has
been evaluated in a double-blind, randomized study. Sixty
women who had undergone gynecological surgery were
given ginger, placebo, or the drug metoclopramide.The
incidence of nausea was significantly lower in the ginger
root group as compared to placebo, and was similar to the
metaclopramide group.28

Digestive EnzymesClinical Studies

In the presence of food, the pancreas releases digestive
enzymes to break down foods into absorbable forms.
Pancreatic enzyme supplements of protease, lipase and
amylase have been found effective in a number of clinical
studies.2935 The use of lactase for lactose intolerance is well
established. Many people do not have the ability to utilize
lactose, and thus it passes through the body unabsorbed,
causing abdominal discomfort, flatulence, diarrhea, nausea,
and vomiting.1820 Several studies have identified that oral
lactase may be helpful in lactose digestion. Oral lactase has
been shown to significantly lower the cumulative index
for gastrointestinal intolerance and decrease hydrogen
production (an indicator of lactose digestion).2122 Clinical
symptoms associated with hydrogen production include
abdominal pain, bloating, flatulence and diarrhea.22
Some individuals may exhibit abdominal symptoms
with the consumption of low-digestible carbohydrates,
including cellulose and fiber.19 Because the human body

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

lacks the enzyme required to digest some fibers,

increased abdominal bloating, heartburn, and flatulence
has been reported.1820 Little human research has been
done, but various animal studies have indicated that
cellulase supplementation may enhance digestibility
of fiber-rich foods.2326

a physician prior to use.There are no known drug

interactions for Artichoke, Ginger, or plant-based
digestive enzymes. Experts have suggested that the
ingredients in this product may be contraindicated in
people with cholelithiasis, bile duct occlusion, cystic
fibrosis, and allergy to the plant components.14,15,27

Proprietary Processing

Directions for Use

The combination of quality ingredients, qualified

manufacturers, certified independent laboratory verification, and a continuous drive to supply leading
edge products, ensure our distributors and consumers
the highest quality products available in the industry.
The constituents in Digestive Formula are standardized
through scientific and analytical methods to ensure that
every capsule contains the specific level of constituents,
every time. Digestive Formulas Artichoke leaf extract
(Cynara scolymus) is standardized to 15% caffeoylquinic
acids, the highest level currently available in the U.S., and
Ginger root extract (Zingiber officinalis) is standardized
to 5% gingerols. Digestive Formula also utilizes a
proprietary blend of plant-based natural enzymes.
All ingredients are tested for purity, and where
applicable, ingredients are certified pure by microbial
testing, such as tests for Salmonella, E. coli, other
coliforms, Staphylococcus aureus, total plate counts,
yeasts, molds and pesticide residues. Our manufacturers
go through a detailed selection and certification process
to assure their compliance with Good Manufacturing
Practice (GMP) standards set by the Food and Drug
Administration (FDA).

Digestive Formula is a dietary supplement for

individuals who want to support healthy digestive
function. As a dietary supplement, take one (1) to
two (2) capsules with meals as needed.

Side Effects

1.

There have been very few reported side effects at the

recommended dosage.The rate of side effects in clinical
trials with Artichoke leaf extract was very low (<2%). A
post marketing surveillance study involving 417 patients
showed good tolerance to Artichoke leaf extract in
95% of the cases.14 The mild side effects reported in
these studies included flatulence and hunger.

How Supplied
Digestive Formula is supplied in a bottle of 60
gelatin capsules. Each capsule provides 200 mg Ginger
root extract, 145 mg Pharmanex Proprietary Enzyme
Blend and 135 mg of Artichoke Leaf Extract.

Storage
Store in a cool, dry place. Avoid excessive heat.
Protect from light.

Shelf Life
Expiration date and lot code numbers are stamped
on the bottle.

Warnings
Keep out of reach of children. If you are pregnant
or nursing, or taking a prescription medication, consult
a physician before using this product.

References
2.
3.
4.
5.

Safety and Toxicity

Digestive Formula is safe and well tolerated at the
recommended dosage. Artichoke, Ginger, and plantbased digestive enzymes can be found in a normal diet.
There are currently no reported toxic effects from
animal or clinical studies involving these ingredients.

6.
7.

8.

Contraindications/Drug Interactions
If you are pregnant or lactating, taking a prescription medication, or have a medical condition, consult

9.

Artichoke ExtractFor the Treatment of Dyspeptic Complaints.

Pittsburg, PA: EuroMed, 1998.
Introduction to the digestive system. In: Fox SI, ed. Human
Physiology. Dubuque, IA; Melbourne, Austrailia; Oxford
England: 1993:486 517.
Anonymous.Artichoke extract: Improves digestion, liver function,
and cholesterol levels. Natural Medicine Journal 1998;1:22 4.
Wegener T, Fintelmann V. [Pharmacological properties and therapeutic profile of artichoke (Cynara scolymus L.)].Wien.Med
Wochenschr. 1999;149:2417.
Ginger Root. In: Blumenthal M, Goldberg A, Brinckmann J, eds.
Herbal MedicineExpanded Commission E Monographs.
Newton, MA: Integrative Medicine Communications
2000:153 9.
Adewunmi C. Molluscicidal and Antischistosomal Activities of
Zingiber officinale. Planta Medica 1990;56.
Bradley P, ed. British Herbal Compendium (BHC).Vol. 1. A
handbook of scientific information on widely used plant drugs.
Bournemouth, Dorset, England: British Herbal Medicine Association 1992:89 91.
Mascolo N, Jain R, Jain SC, Capasso F. Ethnopharmacologic
investigation of ginger (Zingiber officinale). J Ethnopharmacol
1989;27:129 40.
Ramirez FC, Lee K, Graham DY. All lactase preparations are not
the same: results of a prospective, randomized, placebo-controlled
trial. Am J Gastroenterol. 1994;89:566 70.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

10. Lin MY, DiPalma JA, Martini MC, Gross CJ, Harlander SK,
Savaiano DA. Comparative effects of exogenous lactase
(beta-galactosidase) preparations on in vivo lactose digestion.
Dig.Dis.Sci 1993;38:2022 7.
11. Lami F, Callegari C,Tatali M et al. Efficacy of addition of
exogenous lactase to milk in adult lactase deficiency. Am J
Gastroenterol. 1988;83:1145 9.
12. Fintelmann,V. [Artichoke leaf extract]. Z Allg Med
1996;92:3 19,48.
13. Kraft K. Artichoke leaf extractrecent findings reflecting effects
on lipid metabolism, liver and gastrointestinal tracts. Phytomedicine
1997;4:369 78.
14. Lichter Pharma US, Inc. CynaraSL backgroundArtichoke
for the treatment of dyspeptic complaints. 2000:5 9.
15. Artichoke leaf. In: Blumenthal M, Goldberg A, Brinckmann J,
eds. Herbal MedicineExpanded Commission E Monographs.
Newton, MA: Integrative Medicine Communications 2000:10 2.
16. Grontved A, Brask T, Kambskard J, Hentzer E. Ginger root
against seasickness. Acta Oto-Laryngol. 1988;105:45 9.
17. Holtmann S.The Anti-Motion Sickness Mechanisms of Ginger.
Acta Oto 1989;16874.
18. Livesey G.Tolerance of low-digestible carbohydrates: a general
view. Br J Nutr 2001;85 Suppl 1:S716.:S716.
19. Levitt MD, Furne J, Olsson S.The relation of passage of gas an
abdominal bloating to colonic gas production. Ann Intern. Med
1996;124:422 4.
20. Ganiats TG, Norcross WA, Halverson AL, Burford PA, Palinkas
LA. Does Beano prevent gas? A double-blind crossover study of
oral alpha-galactosidase to treat dietary oligosaccharide intolerance. J Fam.Pract 1994;39:4415.
21. Corazza GR, Benati G, Sorge M, Strocchi A, Calza G, Gasbarrini
G. beta-Galactosidase from Aspergillus niger in adult lactose
malabsorption: a double-blind crossover study.Aliment Pharmacol
Ther 1992;6:61 6.
22. Medow MS,Thek KD, Newman LJ, Berezin S, Glassman MS,
Schwarz SM. Beta-galactosidase tablets in the treatment of
lactose intolerance in pediatrics.Am J Dis Child 1990;144:12614.
23. Rode LM,Yang WZ, Beauchemin KA. Fibrolytic enzyme
supplements for dairy cows in early lactation. J Dairy Sci
1999;82:2121 6.
24. Beauchemin KA,Yang WZ, Rode LM. Effects of grain source
and enzyme additive on site and extent of nutrient digestion in
dairy cows. J Dairy Sci 1999;82:378 90.
25. Friesen OD, Guenter W, Rotter BA, Marquardt RR.The effects
of enzyme supplementation on the nutritive value of rye grain
for the young broiler chick. Poult Sci 1991;70:25018.
26. Nahm KH, Carlson CW. Effects of cellulase from Trichoderma
viride on nutrient utilization by broilers. Poult Sci
1985;64:153640.
27. Zempsky WT, Rosenstein BJ, Carroll JA, Oski FA. Effect of
pancreatic enzyme supplements on iron absorption. Am J Dis
Child 1989;143:969 72.
28. Bone ME,Wilkinson DJ,Young JR, McNeil J, Charlton S.
Ginger roota new antiemetic.The effect of ginger root on
postoperative nausea and vomiting after major gynaecological
surgery. Anaesthesia 1990;45:669 71.
29. Bragelmann R, Armbrecht U, Rosemeyer D, Schneider B, Zilly
W, Stockbrugger RW.The effect of pancreatic enzyme supplementation in patients with steatorrhoea after total gastrectomy.
Eur J Gastroenterol Hepatol. 1999;11:2317.
30. Braga M, Cristallo M, De Franchis R et al. Correction of
malnutrition and maldigestion with enzyme supplementation in
patients with surgical suppression of exocrine pancreatic function.
Surg Gynecol Obstet 1988;167:485 92.
31. Ramo OJ, Puolakkainen PA, Seppala K, Schroder TM. Selfadministration of enzyme substitution in the treatment of
exocrine pancreatic insufficiency. Scan J Gastroenterol
1989;24:688 92.
32. Jansen JB, Jebbink MC, Mulders HJ, Lamers CB. Effect of
pancreatic enzyme supplementation on postprandial plasma

cholecystokinin secretion in patients with pancreatic insufficiency. Regul Pept 1989;25:333 42.
33. Andren-Sandberg A.Theory and practice in the individualization
of oral pancreatic enzyme administration for chronic pancreatitis.
Int J Pancreatol. 1989;5 Suppl:51 62.
34. Ansaldi-Balocco N, Santini B, Sarchi C. Efficacy of pancreatic
enzyme supplementation in children with cystic fibrosis:
comparison of two preparations by random crossover study and
a retrospective study of the same patients at two different ages. J
Pediatr Gastroenterol Nutr 1988;7 Suppl 1:S40 5.
35. Petersen W, Heilmann C, Garne S. Pancreatic enzyme supplementation as acid-resistant microspheres versus enteric-coated
granules in cystic fibrosis. A double placebo-controlled crossover study. Acta Paediatr Scan 1987;76:66 9.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

The Pharmanex 6S Quality Process

The Pharmanex 6S Quality Process is central to the Pharmanex
mission of transforming time-honored, traditional preparations into
health promoting botanical products with known content and consistent activity.
Selection

Exhaustive scientific review of research and databases is conducted.

Authenticity, usefulness, and safety standards are determined.

Sourcing

Teams of experts investigate potential sources and evaluate quality.

Comprehensive botanical and chemical evaluations are completed.

Structure

Structural analyses of natural compounds are determined.

Active ingredients are isolated and studied.

Standardization Strict standardization to at least one relevant marker molecule is required.

Proprietary processing methods to increase consistency and ensure measured dose
effectiveness are developed.
Safety

Safety is assessed from available research.

Microbial test, chemical, toxin, and heavy metal analyses are conducted.

Substantiation

Documented pre-clinical and clinical studies are reviewed.

Pharmanex sponsored studies are initiated when appropriate.

For More Information:

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