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

• ClinicalTrials.gov Identifier: NCT03057873
• Recruitment Status: Completed
• First Posted: February 20, 2017
• Last Update Posted: February 4, 2019
• Sponsor: Beachbody
• Collaborators: KGK Science Inc.; Glycemic Index Laboratories, Inc; MB Clinical Research and Consulting LLC
• Information provided by (Responsible Party): Beachbody

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight	Dietary Supplement: High protein, high fiber dietary supplement; Dietary Supplement: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind
• Primary Purpose: Other
• 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
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: October 25, 2018
• Actual Study Completion Date: October 25, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: High protein, high fiber; 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; Dry powder to be mixed with 10 ounces of cold water
Placebo Comparator: Low protein, low fiber; Participants receive a low protein, low fiber supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks	Dietary Supplement: Placebo; Dry powder to be mixed with 10 ounces of cold water

Outcome Measures

Primary Outcome Measures :

1. Change in body weight (kg) [ Time Frame: Baseline and 12 weeks ]
   Body weight measured by clinic study staff at required visits
2. Change in body fat percentage (%) [ Time Frame: Baseline and 12 weeks ]
   Body fat percentage as determined by dual x-ray absorptiometry (DXA)

Secondary Outcome Measures :

1. Change in total fat mass (kg) [ Time Frame: Baseline and 12 weeks ]
   Body fat mass as determined by DXA
2. Change in total lean mass (kg) [ Time Frame: Baseline and 12 weeks ]
   Body lean mass as determined by DXA
3. Change in percent abdominal fat (%) [ Time Frame: Baseline and 12 weeks ]
   Abdominal fat percentage as determined by DXA
4. Change in percent android fat (%) [ Time Frame: Baseline and 12 weeks ]
   Android fat percentage as determined by DXA
5. Change in percent gynoid fat (%) [ Time Frame: Baseline and 12 weeks ]
   Gynoid fat percentage as determined by DXA
6. Change in percent trunk fat (%) [ Time Frame: Baseline and 12 weeks ]
   Trunk fat percentage as determined by DXA
7. Change in percent leg fat (%) [ Time Frame: Baseline and 12 weeks ]
   Leg fat percentage as determined by DXA
8. Change in body weight (kg) [ Time Frame: Baseline and 4 weeks ]
   Body weight measured by clinic study staff at required visits
9. Change in body weight (kg) [ Time Frame: Baseline and 8 weeks ]
   Body weight measured by clinic study staff at required visits
10. Change in Waist circumference (cm) [ Time Frame: Baseline and 4 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
11. Change in Waist circumference (cm) [ Time Frame: Baseline and 8 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
12. Change in Waist circumference (cm) [ Time Frame: 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
13. Change in Hip circumference (cm) [ Time Frame: Baseline and 4 weeks ]
    measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
14. Change in Hip circumference (cm) [ Time Frame: Baseline and 8 weeks ]
    measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
15. Change in Hip circumference (cm) [ Time Frame: Baseline and 12 weeks ]
    measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
16. Change in Waist to hip ratio [ Time Frame: Baseline and 4 weeks ]
    Ratio of waist circumference to hip circumference
17. Change in Waist to hip ratio [ Time Frame: Baseline and 8 weeks ]
    Ratio of waist circumference to hip circumference
18. Change in Waist to hip ratio [ Time Frame: Baseline and 12 weeks ]
    Ratio of waist circumference to hip circumference
19. Change in Blood leptin (ng/mL) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of leptin in the blood
20. Change in Blood adiponectin (mcg/mL) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of adiponectin in the blood
21. Change in Total cholesterol (mg/dL) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of total cholesterol in blood
22. Change in Total cholesterol (mg/dL) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of total cholesterol in blood
23. Change in Total cholesterol (mg/dL) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of total cholesterol in blood
24. Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of LDL cholesterol in blood
25. Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of LDL cholesterol in blood
26. Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of LDL cholesterol in blood
27. Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of HDL cholesterol in blood
28. Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of HDL cholesterol in blood
29. Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of HDL cholesterol in blood
30. Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of Ox-LDL cholesterol in blood
31. Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of Ox-LDL cholesterol in blood
32. Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of Ox-LDL cholesterol in blood
33. Change in triglycerides (mg/dL) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of triglycerides in blood
34. Change in triglycerides (mg/dL) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of triglycerides in blood
35. Change in triglycerides (mg/dL) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of triglycerides in blood
36. Change in Insulin (IU) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of insulin in blood
37. Change in Insulin (IU) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of insulin in blood
38. Change in Insulin (IU) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of insulin in blood
39. Change in Glucose (mmol/L) [ Time Frame: Baseline and 4 weeks ]
    Fasting level of glucose in blood
40. Change in Glucose (mmol/L) [ Time Frame: Baseline and 8 weeks ]
    Fasting level of glucose in blood
41. Change in Glucose (mmol/L) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of glucose in blood
42. Change in blood glycated haemoglobin (HbA1c) (mmol/mol) [ Time Frame: Baseline and 12 weeks ]
    Fasting level of HbA1c in blood
43. Change in gut microbiota composition [ Time Frame: Baseline and 12 weeks ]
    Genera of bacteria measured in stool samples

Other Outcome Measures:

1. Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions [ Time Frame: Baseline and 4 weeks ]
   Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7)
2. Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions [ Time Frame: Baseline and 8 weeks ]
   Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7)
3. Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions [ Time Frame: Baseline and 12 weeks ]
   Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7)
4. Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type) [ Time Frame: Baseline and 4 weeks ]
   Bowel habits assessed for 72-hour period every 2 weeks by bowel habits diary including number of bowel movements per day and classification of stool form type. Data for each time point (4, 8, and 12 weeks) will include 2 diary collections.
5. Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type) [ Time Frame: Baseline and 8 weeks ]
   Bowel habits assessed for 72-hour period every 2 weeks by bowel habits diary including number of bowel movements per day and classification of stool form type. Data for each time point (4, 8, and 12 weeks) will include 2 diary collections.
6. Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type) [ Time Frame: Baseline and 12 weeks ]
   Bowel habits assessed for 72-hour period every 2 weeks by bowel habits diary including number of bowel movements per day and classification of stool form type. Data for each time point (4, 8, and 12 weeks) will include 2 diary collections.
7. Change in systolic blood pressure [ Time Frame: Baseline and 4 weeks ]
   Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart
8. Change in systolic blood pressure [ Time Frame: Baseline and 8 weeks ]
   Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart
9. Change in systolic blood pressure [ Time Frame: Baseline and 12 weeks ]
   Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart
10. Change in diastolic blood pressure [ Time Frame: Baseline and 4 weeks ]
    Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart
11. Change in diastolic blood pressure [ Time Frame: Baseline and 8 weeks ]
    Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart
12. Change in diastolic blood pressure [ Time Frame: Baseline and 12 weeks ]
    Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart
13. Change in Profiles of Mood States (POMS) questionnaire ratings [ Time Frame: Baseline and 4 weeks ]
    Scores for energy, mood, and stress as assessed by POMS questionnaire
14. Change in Profiles of Mood States (POMS) questionnaire ratings [ Time Frame: Baseline and 8 weeks ]
    Scores for energy, mood, and stress as assessed by POMS questionnaire
15. Change in Profiles of Mood States (POMS) questionnaire ratings [ Time Frame: Baseline and 12 weeks ]
    Scores for energy, mood, and stress as assessed by POMS questionnaire
16. Change in Three-factor Eating Questionnaire (TFEQ) scores [ Time Frame: Baseline and 4 weeks ]
    Scores for eating behavior as assessed by TFEQ
17. Change in Three-factor Eating Questionnaire (TFEQ) scores [ Time Frame: Baseline and 8 weeks ]
    Scores for eating behavior as assessed by TFEQ
18. Change in Three-factor Eating Questionnaire (TFEQ) scores [ Time Frame: Baseline and 12 weeks ]
    Scores for eating behavior as assessed by TFEQ
19. Change in Binge Eating Scale (BES) scores [ Time Frame: Baseline and 4 weeks ]
    Scores for binge eating as assessed by BES
20. Change in Binge Eating Scale (BES) scores [ Time Frame: Baseline and 8 weeks ]
    Scores for binge eating as assessed by BES
21. Change in Binge Eating Scale (BES) scores [ Time Frame: Baseline and 12 weeks ]
    Scores for binge eating as assessed by BES
22. Change in number of junk food cravings reported [ Time Frame: Baseline and 4 weeks ]
    Number of cravings as assessed by daily entries in study diary
23. Change in number of junk food cravings reported [ Time Frame: Baseline and 8 weeks ]
    Number of cravings as assessed by daily entries in study diary
24. Change in number of junk food cravings reported [ Time Frame: Baseline and 12 weeks ]
    Number of cravings as assessed by daily entries in study diary
25. Change in IgG levels [ Time Frame: Baseline and 12 weeks ]
    Fasting level of IgG in blood
26. Change in IgA levels [ Time Frame: Baseline and 12 weeks ]
    Fasting level of IgA in blood
27. Change in IgM levels [ Time Frame: Baseline and 12 weeks ]
    Fasting level of IgM in blood
28. Change in Complement C3 levels [ Time Frame: Baseline and 12 weeks ]
    Fasting level of C3 in blood
29. Change in Complement C4 levels [ Time Frame: Baseline and 12 weeks ]
    Fasting level of C4 in blood

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Illinois

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

Chicago, Illinois, United States, 60630

Canada, Ontario

KGK Synergize Inc.

London, Ontario, Canada, N6A 58R

GI Labs, Inc.

Toronto, Ontario, Canada, M5C 2N8

Sponsors and Collaborators

Beachbody

KGK Science Inc.

Glycemic Index Laboratories, Inc

MB Clinical Research and Consulting LLC

Investigators

• Principal Investigator: 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)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Beachbody
• ClinicalTrials.gov Identifier: NCT03057873
• Other Study ID Numbers: 15SWHB
• First Posted: February 20, 2017
• Last Update Posted: February 4, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beachbody:

protein; fiber; weight loss; fat loss

Additional relevant MeSH terms:

Overweight; Body Weight