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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057873
• Other study ID #: 15SWHB
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: October 25, 2018

Study information

• Verified date: January 2019
• Source: Beachbody
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• High protein, high fiber dietary supplement
Dry powder to be mixed with 10 ounces of cold water
• Placebo
Dry powder to be mixed with 10 ounces of cold water

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario
Canada	GI Labs, Inc.	Toronto	Ontario
United States	Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Beachbody	Glycemic Index Laboratories, Inc, KGK Science Inc., MB Clinical Research and Consulting LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions	Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7)	Baseline and 4 weeks
Other	Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions	Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7)	Baseline and 8 weeks
Other	Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions	Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7)	Baseline and 12 weeks
Other	Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type)	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.	Baseline and 4 weeks
Other	Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type)	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.	Baseline and 8 weeks
Other	Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type)	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.	Baseline and 12 weeks
Other	Change in systolic blood pressure	Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart	Baseline and 4 weeks
Other	Change in systolic blood pressure	Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart	Baseline and 8 weeks
Other	Change in systolic blood pressure	Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart	Baseline and 12 weeks
Other	Change in diastolic blood pressure	Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart	Baseline and 4 weeks
Other	Change in diastolic blood pressure	Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart	Baseline and 8 weeks
Other	Change in diastolic blood pressure	Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart	Baseline and 12 weeks
Other	Change in Profiles of Mood States (POMS) questionnaire ratings	Scores for energy, mood, and stress as assessed by POMS questionnaire	Baseline and 4 weeks
Other	Change in Profiles of Mood States (POMS) questionnaire ratings	Scores for energy, mood, and stress as assessed by POMS questionnaire	Baseline and 8 weeks
Other	Change in Profiles of Mood States (POMS) questionnaire ratings	Scores for energy, mood, and stress as assessed by POMS questionnaire	Baseline and 12 weeks
Other	Change in Three-factor Eating Questionnaire (TFEQ) scores	Scores for eating behavior as assessed by TFEQ	Baseline and 4 weeks
Other	Change in Three-factor Eating Questionnaire (TFEQ) scores	Scores for eating behavior as assessed by TFEQ	Baseline and 8 weeks
Other	Change in Three-factor Eating Questionnaire (TFEQ) scores	Scores for eating behavior as assessed by TFEQ	Baseline and 12 weeks
Other	Change in Binge Eating Scale (BES) scores	Scores for binge eating as assessed by BES	Baseline and 4 weeks
Other	Change in Binge Eating Scale (BES) scores	Scores for binge eating as assessed by BES	Baseline and 8 weeks
Other	Change in Binge Eating Scale (BES) scores	Scores for binge eating as assessed by BES	Baseline and 12 weeks
Other	Change in number of junk food cravings reported	Number of cravings as assessed by daily entries in study diary	Baseline and 4 weeks
Other	Change in number of junk food cravings reported	Number of cravings as assessed by daily entries in study diary	Baseline and 8 weeks
Other	Change in number of junk food cravings reported	Number of cravings as assessed by daily entries in study diary	Baseline and 12 weeks
Other	Change in IgG levels	Fasting level of IgG in blood	Baseline and 12 weeks
Other	Change in IgA levels	Fasting level of IgA in blood	Baseline and 12 weeks
Other	Change in IgM levels	Fasting level of IgM in blood	Baseline and 12 weeks
Other	Change in Complement C3 levels	Fasting level of C3 in blood	Baseline and 12 weeks
Other	Change in Complement C4 levels	Fasting level of C4 in blood	Baseline and 12 weeks
Primary	Change in body weight (kg)	Body weight measured by clinic study staff at required visits	Baseline and 12 weeks
Primary	Change in body fat percentage (%)	Body fat percentage as determined by dual x-ray absorptiometry (DXA)	Baseline and 12 weeks
Secondary	Change in total fat mass (kg)	Body fat mass as determined by DXA	Baseline and 12 weeks
Secondary	Change in total lean mass (kg)	Body lean mass as determined by DXA	Baseline and 12 weeks
Secondary	Change in percent abdominal fat (%)	Abdominal fat percentage as determined by DXA	Baseline and 12 weeks
Secondary	Change in percent android fat (%)	Android fat percentage as determined by DXA	Baseline and 12 weeks
Secondary	Change in percent gynoid fat (%)	Gynoid fat percentage as determined by DXA	Baseline and 12 weeks
Secondary	Change in percent trunk fat (%)	Trunk fat percentage as determined by DXA	Baseline and 12 weeks
Secondary	Change in percent leg fat (%)	Leg fat percentage as determined by DXA	Baseline and 12 weeks
Secondary	Change in body weight (kg)	Body weight measured by clinic study staff at required visits	Baseline and 4 weeks
Secondary	Change in body weight (kg)	Body weight measured by clinic study staff at required visits	Baseline and 8 weeks
Secondary	Change in Waist circumference (cm)	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	Baseline and 4 weeks
Secondary	Change in Waist circumference (cm)	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	Baseline and 8 weeks
Secondary	Change in Waist circumference (cm)	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	Baseline and 12 weeks
Secondary	Change in Hip circumference (cm)	measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)	Baseline and 4 weeks
Secondary	Change in Hip circumference (cm)	measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)	Baseline and 8 weeks
Secondary	Change in Hip circumference (cm)	measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)	Baseline and 12 weeks
Secondary	Change in Waist to hip ratio	Ratio of waist circumference to hip circumference	Baseline and 4 weeks
Secondary	Change in Waist to hip ratio	Ratio of waist circumference to hip circumference	Baseline and 8 weeks
Secondary	Change in Waist to hip ratio	Ratio of waist circumference to hip circumference	Baseline and 12 weeks
Secondary	Change in Blood leptin (ng/mL)	Fasting level of leptin in the blood	Baseline and 12 weeks
Secondary	Change in Blood adiponectin (mcg/mL)	Fasting level of adiponectin in the blood	Baseline and 12 weeks
Secondary	Change in Total cholesterol (mg/dL)	Fasting level of total cholesterol in blood	Baseline and 4 weeks
Secondary	Change in Total cholesterol (mg/dL)	Fasting level of total cholesterol in blood	Baseline and 8 weeks
Secondary	Change in Total cholesterol (mg/dL)	Fasting level of total cholesterol in blood	Baseline and 12 weeks
Secondary	Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)	Fasting level of LDL cholesterol in blood	Baseline and 4 weeks
Secondary	Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)	Fasting level of LDL cholesterol in blood	Baseline and 8 weeks
Secondary	Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)	Fasting level of LDL cholesterol in blood	Baseline and 12 weeks
Secondary	Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)	Fasting level of HDL cholesterol in blood	Baseline and 4 weeks
Secondary	Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)	Fasting level of HDL cholesterol in blood	Baseline and 8 weeks
Secondary	Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)	Fasting level of HDL cholesterol in blood	Baseline and 12 weeks
Secondary	Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)	Fasting level of Ox-LDL cholesterol in blood	Baseline and 4 weeks
Secondary	Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)	Fasting level of Ox-LDL cholesterol in blood	Baseline and 8 weeks
Secondary	Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)	Fasting level of Ox-LDL cholesterol in blood	Baseline and 12 weeks
Secondary	Change in triglycerides (mg/dL)	Fasting level of triglycerides in blood	Baseline and 4 weeks
Secondary	Change in triglycerides (mg/dL)	Fasting level of triglycerides in blood	Baseline and 8 weeks
Secondary	Change in triglycerides (mg/dL)	Fasting level of triglycerides in blood	Baseline and 12 weeks
Secondary	Change in Insulin (IU)	Fasting level of insulin in blood	Baseline and 4 weeks
Secondary	Change in Insulin (IU)	Fasting level of insulin in blood	Baseline and 8 weeks
Secondary	Change in Insulin (IU)	Fasting level of insulin in blood	Baseline and 12 weeks
Secondary	Change in Glucose (mmol/L)	Fasting level of glucose in blood	Baseline and 4 weeks
Secondary	Change in Glucose (mmol/L)	Fasting level of glucose in blood	Baseline and 8 weeks
Secondary	Change in Glucose (mmol/L)	Fasting level of glucose in blood	Baseline and 12 weeks
Secondary	Change in blood glycated haemoglobin (HbA1c) (mmol/mol)	Fasting level of HbA1c in blood	Baseline and 12 weeks
Secondary	Change in gut microbiota composition	Genera of bacteria measured in stool samples	Baseline and 12 weeks