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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: High protein, high fiber dietary supplement

• Registration Number: NCT03057873
• Lead Sponsor: Beachbody

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-20
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low protein, low fiber	Placebo	Participants receive a low protein, low fiber supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks
High protein, high fiber	High protein, high fiber dietary supplement	Participants receive a high protein, high fiber dietary supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in body weight (kg)	Baseline and 12 weeks	Body weight measured by clinic study staff at required visits
Change in body fat percentage (%)	Baseline and 12 weeks	Body fat percentage as determined by dual x-ray absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
Change in gut microbiota composition	Baseline and 12 weeks	Genera of bacteria measured in stool samples
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)	Baseline and 12 weeks	Fasting level of LDL cholesterol in blood
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)	Baseline and 12 weeks	Fasting level of HDL cholesterol in blood
Change in Glucose (mmol/L)	Baseline and 12 weeks	Fasting level of glucose in blood
Change in total fat mass (kg)	Baseline and 12 weeks	Body fat mass as determined by DXA
Change in percent trunk fat (%)	Baseline and 12 weeks	Trunk fat percentage as determined by DXA
Change in percent leg fat (%)	Baseline and 12 weeks	Leg fat percentage as determined by DXA
Change in body weight (kg)	Baseline and 8 weeks	Body weight measured by clinic study staff at required visits
Change in Hip circumference (cm)	Baseline and 12 weeks	measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Change in Waist to hip ratio	Baseline and 12 weeks	Ratio of waist circumference to hip circumference
Change in blood glycated haemoglobin (HbA1c) (mmol/mol)	Baseline and 12 weeks	Fasting level of HbA1c in blood
Change in percent abdominal fat (%)	Baseline and 12 weeks	Abdominal fat percentage as determined by DXA
Change in percent android fat (%)	Baseline and 12 weeks	Android fat percentage as determined by DXA
Change in percent gynoid fat (%)	Baseline and 12 weeks	Gynoid fat percentage as determined by DXA
Change in Waist circumference (cm)	Baseline and 12 weeks	measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Change in Total cholesterol (mg/dL)	Baseline and 12 weeks	Fasting level of total cholesterol in blood
Change in Insulin (IU)	Baseline and 12 weeks	Fasting level of insulin in blood
Change in total lean mass (kg)	Baseline and 12 weeks	Body lean mass as determined by DXA
Change in Blood leptin (ng/mL)	Baseline and 12 weeks	Fasting level of leptin in the blood
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)	Baseline and 12 weeks	Fasting level of Ox-LDL cholesterol in blood
Change in Blood adiponectin (mcg/mL)	Baseline and 12 weeks	Fasting level of adiponectin in the blood
Change in triglycerides (mg/dL)	Baseline and 12 weeks	Fasting level of triglycerides in blood

Trial Locations

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