Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
| Glycemic Index Laboratories, Inc | INDUSTRY |
| MB Clinical Research and Consulting LLC | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High protein, high fiber | Experimental | Participants receive a high protein, high fiber dietary supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks |
|
| Low protein, low fiber | Placebo Comparator | Participants receive a low protein, low fiber supplement twice daily (30 minutes before breakfast and lunch) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High protein, high fiber dietary supplement | Dietary Supplement | Dry powder to be mixed with 10 ounces of cold water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (kg) | Body weight measured by clinic study staff at required visits | Baseline and 12 weeks |
| Change in body fat percentage (%) | Body fat percentage as determined by dual x-ray absorptiometry (DXA) | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total fat mass (kg) | Body fat mass as determined by DXA | Baseline and 12 weeks |
| Change in total lean mass (kg) | Body lean mass as determined by DXA |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions |
Inclusion Criteria:
Male or female of 25-50 years of age
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:
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.
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)
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
Agrees to fully comply with all study procedures
Has given voluntary written and informed consent to participate in the study
Determined to be healthy as per laboratory parameters and physical examination
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC) | Chicago | Illinois | 60630 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35212740 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind
| Placebo | Dietary Supplement | Dry powder to be mixed with 10 ounces of cold water |
|
| Baseline and 12 weeks |
| Change in percent abdominal fat (%) | Abdominal fat percentage as determined by DXA | Baseline and 12 weeks |
| Change in percent android fat (%) | Android fat percentage as determined by DXA | Baseline and 12 weeks |
| Change in percent gynoid fat (%) | Gynoid fat percentage as determined by DXA | Baseline and 12 weeks |
| Change in percent trunk fat (%) | Trunk fat percentage as determined by DXA | Baseline and 12 weeks |
| Change in percent leg fat (%) | Leg fat percentage as determined by DXA | Baseline and 12 weeks |
| Change in body weight (kg) | Body weight measured by clinic study staff at required visits | Baseline and 4 weeks |
| Change in body weight (kg) | Body weight measured by clinic study staff at required visits | Baseline and 8 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Waist to hip ratio | Ratio of waist circumference to hip circumference | Baseline and 4 weeks |
| Change in Waist to hip ratio | Ratio of waist circumference to hip circumference | Baseline and 8 weeks |
| Change in Waist to hip ratio | Ratio of waist circumference to hip circumference | Baseline and 12 weeks |
| Change in Blood leptin (ng/mL) | Fasting level of leptin in the blood | Baseline and 12 weeks |
| Change in Blood adiponectin (mcg/mL) | Fasting level of adiponectin in the blood | Baseline and 12 weeks |
| Change in Total cholesterol (mg/dL) | Fasting level of total cholesterol in blood | Baseline and 4 weeks |
| Change in Total cholesterol (mg/dL) | Fasting level of total cholesterol in blood | Baseline and 8 weeks |
| Change in Total cholesterol (mg/dL) | Fasting level of total cholesterol in blood | Baseline and 12 weeks |
| Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) | Fasting level of LDL cholesterol in blood | Baseline and 4 weeks |
| Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) | Fasting level of LDL cholesterol in blood | Baseline and 8 weeks |
| Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) | Fasting level of LDL cholesterol in blood | Baseline and 12 weeks |
| Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) | Fasting level of HDL cholesterol in blood | Baseline and 4 weeks |
| Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) | Fasting level of HDL cholesterol in blood | Baseline and 8 weeks |
| Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) | Fasting level of HDL cholesterol in blood | Baseline and 12 weeks |
| Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) | Fasting level of Ox-LDL cholesterol in blood | Baseline and 4 weeks |
| Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) | Fasting level of Ox-LDL cholesterol in blood | Baseline and 8 weeks |
| Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) | Fasting level of Ox-LDL cholesterol in blood | Baseline and 12 weeks |
| Change in triglycerides (mg/dL) | Fasting level of triglycerides in blood | Baseline and 4 weeks |
| Change in triglycerides (mg/dL) | Fasting level of triglycerides in blood | Baseline and 8 weeks |
| Change in triglycerides (mg/dL) | Fasting level of triglycerides in blood | Baseline and 12 weeks |
| Change in Insulin (IU) | Fasting level of insulin in blood | Baseline and 4 weeks |
| Change in Insulin (IU) | Fasting level of insulin in blood | Baseline and 8 weeks |
| Change in Insulin (IU) | Fasting level of insulin in blood | Baseline and 12 weeks |
| Change in Glucose (mmol/L) | Fasting level of glucose in blood | Baseline and 4 weeks |
| Change in Glucose (mmol/L) | Fasting level of glucose in blood | Baseline and 8 weeks |
| Change in Glucose (mmol/L) | Fasting level of glucose in blood | Baseline and 12 weeks |
| Change in blood glycated haemoglobin (HbA1c) (mmol/mol) | Fasting level of HbA1c in blood | Baseline and 12 weeks |
| Change in gut microbiota composition | Genera of bacteria measured in stool samples | Baseline and 12 weeks |
Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7) |
| Baseline and 8 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Profiles of Mood States (POMS) questionnaire ratings | Scores for energy, mood, and stress as assessed by POMS questionnaire | Baseline and 4 weeks |
| Change in Profiles of Mood States (POMS) questionnaire ratings | Scores for energy, mood, and stress as assessed by POMS questionnaire | Baseline and 8 weeks |
| Change in Profiles of Mood States (POMS) questionnaire ratings | Scores for energy, mood, and stress as assessed by POMS questionnaire | Baseline and 12 weeks |
| Change in Three-factor Eating Questionnaire (TFEQ) scores | Scores for eating behavior as assessed by TFEQ | Baseline and 4 weeks |
| Change in Three-factor Eating Questionnaire (TFEQ) scores | Scores for eating behavior as assessed by TFEQ | Baseline and 8 weeks |
| Change in Three-factor Eating Questionnaire (TFEQ) scores | Scores for eating behavior as assessed by TFEQ | Baseline and 12 weeks |
| Change in Binge Eating Scale (BES) scores | Scores for binge eating as assessed by BES | Baseline and 4 weeks |
| Change in Binge Eating Scale (BES) scores | Scores for binge eating as assessed by BES | Baseline and 8 weeks |
| Change in Binge Eating Scale (BES) scores | Scores for binge eating as assessed by BES | Baseline and 12 weeks |
| Change in number of junk food cravings reported | Number of cravings as assessed by daily entries in study diary | Baseline and 4 weeks |
| Change in number of junk food cravings reported | Number of cravings as assessed by daily entries in study diary | Baseline and 8 weeks |
| Change in number of junk food cravings reported | Number of cravings as assessed by daily entries in study diary | Baseline and 12 weeks |
| Change in IgG levels | Fasting level of IgG in blood | Baseline and 12 weeks |
| Change in IgA levels | Fasting level of IgA in blood | Baseline and 12 weeks |
| Change in IgM levels | Fasting level of IgM in blood | Baseline and 12 weeks |
| Change in Complement C3 levels | Fasting level of C3 in blood | Baseline and 12 weeks |
| Change in Complement C4 levels | Fasting level of C4 in blood | Baseline and 12 weeks |
| KGK Synergize Inc. |
| London |
| Ontario |
| N6A 58R |
| Canada |
| GI Labs, Inc. | Toronto | Ontario | M5C 2N8 | Canada |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |