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

NCT03057873 | Completed

• 1 other identifier: 15SWHB
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Overweight

Keywords

protein; fiber; weight loss; fat loss

Outcome Measures

Primary Outcomes (2)

• Change in body weight (kg)

  Body weight measured by clinic study staff at required visits

  Baseline and 12 weeks

• Change in body fat percentage (%)

  Body fat percentage as determined by dual x-ray absorptiometry (DXA)

  Baseline and 12 weeks

Secondary Outcomes (43)

• Change in total fat mass (kg)

  Baseline and 12 weeks

• Change in total lean mass (kg)

  Baseline and 12 weeks

• Change in percent abdominal fat (%)

  Baseline and 12 weeks

• Change in percent android fat (%)

  Baseline and 12 weeks

• Change in percent gynoid fat (%)

  Baseline and 12 weeks

Other Outcomes (29)

• Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions

  Baseline and 4 weeks

• Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions

  Baseline and 8 weeks

• Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions

  Baseline and 12 weeks

Study Arms (2)

High protein, high fiber

EXPERIMENTAL

Participants receive a high protein, high fiber dietary supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks

Dietary Supplement: High protein, high fiber dietary supplement

Low protein, low fiber

PLACEBO COMPARATOR

Participants receive a low protein, low fiber supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks

Dietary Supplement: Placebo

Interventions

High protein, high fiber dietary supplement DIETARY_SUPPLEMENT

Dry powder to be mixed with 10 ounces of cold water

High protein, high fiber

Placebo DIETARY_SUPPLEMENT

Dry powder to be mixed with 10 ounces of cold water

Low protein, low fiber

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female of 25-50 years of age
• 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
• 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)
• 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
• Agrees to fully comply with all study procedures
• Has given voluntary written and informed consent to participate in the study
• Determined to be healthy as per laboratory parameters and physical examination

You may not qualify if:

• Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study
• Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past 1 year from screening
• 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
• Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
• 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
• Subjects with a history of eating disorders
• 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.)
• 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
• Medical history of hypercholesterolipidemia
• Use of cholesterol lowering prescription drugs within the last 6 months
• Fasting TGs ≥ 200 mg/dL (2.26 mmol/L) or a fasting total cholesterol ≥ 240 mg/dL (6.216 mmol/L)
• Fasting glucose ≥ 126 mg/dL
• 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
• Type I or Type II diabetes or use of diabetes medication in a preventative setting.
• History of gastrointestinal dysfunction or surgery that may influence digestion or absorption

Sponsors & Collaborators

• Beachbody: lead
• KGK Science Inc.: collaborator
• Glycemic Index Laboratories, Inc: collaborator
• MB Clinical Research and Consulting LLC: collaborator

Study Sites (3)

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

Chicago, Illinois, 60630, United States

Location

KGK Synergize Inc.

London, Ontario, N6A 58R, Canada

Location

GI Labs, Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• Glynn EL, Fleming SA, Edwards CG, Wilson MJ, Evans M, Leidy HJ. Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial. J Nutr. 2022 Jun 9;152(6):1415-1425. doi: 10.1093/jn/nxac038.

  PMID: 35212740 DERIVED

MeSH Terms

Conditions

Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

• Thomas Wolever, MD, PhD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

• Rupal Trivedi, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 20, 2017
• Study Start: February 13, 2017
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

CA (2); US (1)