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

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ClinicalTrials.gov Identifier: NCT03057873
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
KGK Synergize Inc.
Glycemic Index Laboratories, Inc
MB Clinical Research and Consulting LLC
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057873


Contacts
Contact: Mal Evans, PhD 5194389374 ext 239 mevans@kgksynergize.com

Locations
United States, Illinois
Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC) Recruiting
Chicago, Illinois, United States, 60630
Contact: Steve Satek    773-275-3500    ssatek@greatlakesclinicaltrials.com   
Canada, Ontario
KGK Synergize Inc. Recruiting
London, Ontario, Canada, N6A 58R
Contact: Mal Evans, PhD    5194389374 ext 239    mevans@kgkscience.com   
GI Labs, Inc. Recruiting
Toronto, Ontario, Canada, M5C 2N8
Contact: Alexandra Jenkins, PhD, RD       AEzatagha@gilabs.com   
Sponsors and Collaborators
Beachbody
KGK Synergize Inc.
Glycemic Index Laboratories, Inc
MB Clinical Research and Consulting LLC
Investigators
Principal Investigator: David Crowley, MD KGK Synergize 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)

Responsible Party: Beachbody
ClinicalTrials.gov Identifier: NCT03057873     History of Changes
Other Study ID Numbers: 15SWHB
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

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
Signs and Symptoms