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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: High protein, high fiber dietary supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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 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: Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past 1 year from screening 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 Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients 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 Subjects with a history of eating disorders 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.) 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 Medical history of hypercholesterolipidemia Use of cholesterol lowering prescription drugs within the last 6 months Fasting TGs ≥ 200 mg/dL (2.26 mmol/L) or a fasting total cholesterol ≥ 240 mg/dL (6.216 mmol/L) Fasting glucose ≥ 126 mg/dL 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 Type I or Type II diabetes or use of diabetes medication in a preventative setting. History of gastrointestinal dysfunction or surgery that may influence digestion or absorption 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) Subjects who have a history of colorectal cancer, bowel resection, rectocele, or colostomy Immunocompromised individuals such as subjects that have undergone organ transplantation, those with rheumatoid arthritis, or subjects diagnosed with human immunodeficiency virus (HIV) Unstable medical conditions that in the opinion of the Qualified Investigator preclude the subject from participating in the study Anti-anxiety and anti-psychotic medications will be assessed by the MD on a case by case basis Alcohol use > 2 standard alcoholic drinks per day Alcohol or drug abuse within the last 6 months Use of medicinal marijuana Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative Subjects with metal fixation plates or screws from a previous surgery Clinically significant abnormal laboratory results at screening Participation in a clinical research trial within 30 days prior to randomization Allergy or sensitivity to study supplement ingredients Individuals who are cognitively impaired and/or who are unable to give informed consent 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 Unwilling or unable to comply with study timeline and procedures Individuals who do not like the taste of chocolate or shake type drinks

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein, fiber, weight loss, fat loss