The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:25 - 50
Updated:2/6/2019
Start Date:February 13, 2017
End Date:October 25, 2018

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A Double Blind, Placebo Controlled Parallel Study to Investigate the Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss in Healthy Overweight Adults

The objective of this study is to investigate the effect of a high protein, high fiber
dietary supplement on weight and fat loss in healthy overweight adults. Half of participants
will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the
subjects will receive a placebo (that contains the same amount of calories as the supplement)
twice a day for 12 weeks.


Inclusion Criteria:

1. Male or female of 25-50 years of age

2. If female, the subject is not of child bearing potential, which is defined as females
who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are
post-menopausal (natural or surgically with > 1 year since last menstruation) OR

Females of childbearing potential must agree to use a medically approved method of
birth control and have a negative urine pregnancy test result at screening. Acceptable
methods of birth control include:

- Hormonal contraceptives including oral contraceptives, hormone birth control
patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) for
at least 3 months

- Double-barrier method

- Non-hormonal IUDs

- Hormonal IUD methods must be a stable dose for at least 3 months

- Vasectomy of partner

- Non-heterosexual lifestyle

3. A BMI between 27.0 - <35.0 kg/m2 (inclusive). Subjects must meet exactly the inclusion
BMI at screening, or be screen failed. Subjects who meet the BMI requirement at
screening and present at run-in with a BMI of <27.0 or >35 kg/m2 will be counselled.

4. Subjects that have had a stable weight for the past 6 months. A stable weight is
defined as not having gained or lost more than 5 kg of body weight throughout the past
6 months (cycling of weight, for example, continuously up and down anything less than
5 kg is considered stable)

5. Agreement to comply with dietary recommendations from nutritionist throughout the
duration of the study that include a 500 kcal energy deficit from their predicted
total energy requirements

6. Agrees to fully comply with all study procedures

7. Has given voluntary written and informed consent to participate in the study

8. Determined to be healthy as per laboratory parameters and physical examination

Exclusion Criteria:

1. Females who are pregnant, breastfeeding or planning to become pregnant during the
course of the study

2. Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past
1 year from screening

3. Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe
that they have an allergy to milk or milk products, crustacean shellfish, tree nuts,
or peanuts

4. Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the
product is manufactured in a facility that contains these ingredients

5. The use of prescription, over-the-counter health products, or natural health
products/dietary supplements being taken for weight loss, cholesterol levels, or blood
pressure within 4 weeks of screening

6. Subjects with a history of eating disorders

7. Current participation or participation within the last 3 months in any weight loss
program or diet (for example Weight Watchers, Jenny Craig, DASH diet, Atkins,
Mediterranean etc.)

8. Medical history of thyroid disorders except for subjects diagnosed with hypothyroid
and have been on stable medication for at least the last 3 months prior to enrollment.
All subject with medical history of hyperthyroid are excluded

9. Medical history of hypercholesterolipidemia

10. Use of cholesterol lowering prescription drugs within the last 6 months

11. Fasting TGs ≥ 200 mg/dL (2.26 mmol/L) or a fasting total cholesterol ≥ 240 mg/dL
(6.216 mmol/L)

12. Fasting glucose ≥ 126 mg/dL

13. Hypertension defined as untreated systolic blood pressure >160 mmHg, diastolic blood
pressure >100 mmHg, or the use of prescription high blood pressure/hypertension
medications within the last 6 months

14. Type I or Type II diabetes or use of diabetes medication in a preventative setting.

15. History of gastrointestinal dysfunction or surgery that may influence digestion or
absorption

16. Chronic inflammation or structural abnormality, including history of, of the digestive
tract (inflammatory bowel disease, celiac disease, chronic diarrhea, chronic
constipation, duodenal or gastric ulcer, gastric retention or obstruction,
Gastroesophageal reflux disease (GERD), or symptomatic cholelithiasis)

17. Subjects who have a history of colorectal cancer, bowel resection, rectocele, or
colostomy

18. Immunocompromised individuals such as subjects that have undergone organ
transplantation, those with rheumatoid arthritis, or subjects diagnosed with human
immunodeficiency virus (HIV)

19. Unstable medical conditions that in the opinion of the Qualified Investigator preclude
the subject from participating in the study

20. Anti-anxiety and anti-psychotic medications will be assessed by the MD on a case by
case basis

21. Alcohol use > 2 standard alcoholic drinks per day

22. Alcohol or drug abuse within the last 6 months

23. Use of medicinal marijuana

24. Cancer, except skin cancers completely excised with no chemotherapy or radiation with
a follow up that is negative

25. Subjects with metal fixation plates or screws from a previous surgery

26. Clinically significant abnormal laboratory results at screening

27. Participation in a clinical research trial within 30 days prior to randomization

28. Allergy or sensitivity to study supplement ingredients

29. Individuals who are cognitively impaired and/or who are unable to give informed
consent

30. Any other condition which in the Investigator's opinion may adversely affect the
subject's ability to complete the study or its measures or which may pose significant
risk to the subject

31. Unwilling or unable to comply with study timeline and procedures

32. Individuals who do not like the taste of chocolate or shake type drinks
We found this trial at
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London, Ontario
Phone: 5194389374
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