Clinical trial NCT03057873: The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: protein
fiber
weight loss
fat loss
Lead sponsor: Beachbody
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
name: Glycemic Index Laboratories, Inc
name: MB Clinical Research and Consulting LLC
First posted: 2017-02-20
Enrollment: 206
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight (kg)
timeFrame: Baseline and 12 weeks
measure: Change in body fat percentage (%)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in total fat mass (kg)
timeFrame: Baseline and 12 weeks
measure: Change in total lean mass (kg)
timeFrame: Baseline and 12 weeks
measure: Change in percent abdominal fat (%)
timeFrame: Baseline and 12 weeks
measure: Change in percent android fat (%)
timeFrame: Baseline and 12 weeks
measure: Change in percent gynoid fat (%)
timeFrame: Baseline and 12 weeks
measure: Change in percent trunk fat (%)
timeFrame: Baseline and 12 weeks
measure: Change in percent leg fat (%)
timeFrame: Baseline and 12 weeks
measure: Change in body weight (kg)
timeFrame: Baseline and 4 weeks
measure: Change in body weight (kg)
timeFrame: Baseline and 8 weeks
measure: Change in Waist circumference (cm)
timeFrame: Baseline and 4 weeks
measure: Change in Waist circumference (cm)
timeFrame: Baseline and 8 weeks
measure: Change in Waist circumference (cm)
timeFrame: Baseline and 12 weeks
measure: Change in Hip circumference (cm)
timeFrame: Baseline and 4 weeks
measure: Change in Hip circumference (cm)
timeFrame: Baseline and 8 weeks
measure: Change in Hip circumference (cm)
timeFrame: Baseline and 12 weeks
measure: Change in Waist to hip ratio
timeFrame: Baseline and 4 weeks
measure: Change in Waist to hip ratio
timeFrame: Baseline and 8 weeks
measure: Change in Waist to hip ratio
timeFrame: Baseline and 12 weeks
measure: Change in Blood leptin (ng/mL)
timeFrame: Baseline and 12 weeks
measure: Change in Blood adiponectin (mcg/mL)
timeFrame: Baseline and 12 weeks
measure: Change in Total cholesterol (mg/dL)
timeFrame: Baseline and 4 weeks
measure: Change in Total cholesterol (mg/dL)
timeFrame: Baseline and 8 weeks
measure: Change in Total cholesterol (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
timeFrame: Baseline and 4 weeks
measure: Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
timeFrame: Baseline and 8 weeks
measure: Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
timeFrame: Baseline and 4 weeks
measure: Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
timeFrame: Baseline and 8 weeks
measure: Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
timeFrame: Baseline and 4 weeks
measure: Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
timeFrame: Baseline and 8 weeks
measure: Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
timeFrame: Baseline and 12 weeks
measure: Change in triglycerides (mg/dL)
timeFrame: Baseline and 4 weeks
measure: Change in triglycerides (mg/dL)
timeFrame: Baseline and 8 weeks
measure: Change in triglycerides (mg/dL)
timeFrame: Baseline and 12 weeks
measure: Change in Insulin (IU)
timeFrame: Baseline and 4 weeks
measure: Change in Insulin (IU)
timeFrame: Baseline and 8 weeks
measure: Change in Insulin (IU)
timeFrame: Baseline and 12 weeks
measure: Change in Glucose (mmol/L)
timeFrame: Baseline and 4 weeks
measure: Change in Glucose (mmol/L)
timeFrame: Baseline and 8 weeks
measure: Change in Glucose (mmol/L)
timeFrame: Baseline and 12 weeks
measure: Change in blood glycated haemoglobin (HbA1c) (mmol/mol)
timeFrame: Baseline and 12 weeks
measure: Change in gut microbiota composition
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions
timeFrame: Baseline and 4 weeks
measure: Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions
timeFrame: Baseline and 8 weeks
measure: Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions
timeFrame: Baseline and 12 weeks
measure: Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type)
timeFrame: Baseline and 4 weeks
measure: Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type)
timeFrame: Baseline and 8 weeks
measure: Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type)
timeFrame: Baseline and 12 weeks
measure: Change in systolic blood pressure
timeFrame: Baseline and 4 weeks
measure: Change in systolic blood pressure
timeFrame: Baseline and 8 weeks
measure: Change in systolic blood pressure
timeFrame: Baseline and 12 weeks
measure: Change in diastolic blood pressure
timeFrame: Baseline and 4 weeks
measure: Change in diastolic blood pressure
timeFrame: Baseline and 8 weeks
measure: Change in diastolic blood pressure
timeFrame: Baseline and 12 weeks
measure: Change in Profiles of Mood States (POMS) questionnaire ratings
timeFrame: Baseline and 4 weeks
measure: Change in Profiles of Mood States (POMS) questionnaire ratings
timeFrame: Baseline and 8 weeks
measure: Change in Profiles of Mood States (POMS) questionnaire ratings
timeFrame: Baseline and 12 weeks
measure: Change in Three-factor Eating Questionnaire (TFEQ) scores
timeFrame: Baseline and 4 weeks
measure: Change in Three-factor Eating Questionnaire (TFEQ) scores
timeFrame: Baseline and 8 weeks
measure: Change in Three-factor Eating Questionnaire (TFEQ) scores
timeFrame: Baseline and 12 weeks
measure: Change in Binge Eating Scale (BES) scores
timeFrame: Baseline and 4 weeks
measure: Change in Binge Eating Scale (BES) scores
timeFrame: Baseline and 8 weeks
measure: Change in Binge Eating Scale (BES) scores
timeFrame: Baseline and 12 weeks
measure: Change in number of junk food cravings reported
timeFrame: Baseline and 4 weeks
measure: Change in number of junk food cravings reported
timeFrame: Baseline and 8 weeks
measure: Change in number of junk food cravings reported
timeFrame: Baseline and 12 weeks
measure: Change in IgG levels
timeFrame: Baseline and 12 weeks
measure: Change in IgA levels
timeFrame: Baseline and 12 weeks
measure: Change in IgM levels
timeFrame: Baseline and 12 weeks
measure: Change in Complement C3 levels
timeFrame: Baseline and 12 weeks
measure: Change in Complement C4 levels
timeFrame: Baseline and 12 weeks
Locations:
city: Chicago
country: United States
facility: Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)
state: Illinois
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
city: Toronto
country: Canada
facility: GI Labs, Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)
name: Rupal Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.