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The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03057873•Beachbody

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

25 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.
+5 more criteria

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
+22 more criteria

Locations (3)

Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)

Chicago, Illinois, United States

KGK Synergize Inc.

London, Ontario, Canada

GI Labs, Inc.

Toronto, Ontario, Canada

Key Dates

Start Date

February 13, 2017

Primary Completion Date

October 25, 2018

Completion Date

October 25, 2018

Last Updated

February 4, 2019

Enrollment

206

ACTUAL participants

Conditions

Overweight

Interventions

High protein, high fiber dietary supplement

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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