Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults

Study Overview
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Brief Summary
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To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight but otherwise healthy adults.

Detailed Description
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Hypothesis The investigator's hypothesize that daily intake for a 3-month period of the ISOThrive supplement vs. a placebo will demonstrate beneficial effects on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight adults. Specific Aims To determine the effects of the ISOThrive supplement on body weight in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate a clinically meaningful reduction in body weight in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement. To determine the effects of the ISOThrive supplement on hunger/satiety, body composition, waist circumference, blood pressure, blood glucose levels, blood lipid levels, inflammatory and satiety serum markers and self-reported quality of life in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate an improvement in hunger/satiety and a clinically meaningful improvement in other measures in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement. To demonstrate the safety of the ISOThrive supplement in terms of its impact on blood, liver and kidney function in overweight adults. Specifically, to demonstrate the lack of a negative impact on blood, liver and kidney function tests in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement. To determine the effects of the ISOThrive supplement on Gut health. Specifically, to demonstrate improvement in Gut health as measured by abdominal bloating, abdominal gas, and abdominal pain/discomfort at the end of 3 months of daily consumption of the ISOThrive supplement.

Official Title
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Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: ISOThrive Supplement
* Dietary Supplement: Placebo Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of 25 and over and weight not > 350lb Age between 18 and 75 Non-smokers Able to read and write in English Exclusion Criteria: Pregnant and/or lactating women Evidence or history of substance or alcohol abuse (include if over 5years) History of major depression, bipolar disorder or schizophrenia, any type of obsessive-compulsive disorder Current history of migraine headaches (include if controlled with medication) Current use of any prescription or non-prescription weight loss products Tobacco use Active eating disorder including anorexia nervosa and bulimia Known sensitivity or allergy to any of the ingredients in the product Symptomatic coronary artery disease or congestive heart failure History of a stroke in the past year Symptomatic arrhythmia Uncontrolled hypertension (i.e. systolic pressure >180 mmHg and or diastolic > 110 mmHg) History of a seizure in the past 5 years Any cancer in the past 5 years other than non-melanoma skin cancer or in-situ cervical cancer Active or history of inflammatory bowel disease Current use of TNF-alpha inhibitor medications Current use of COX-2 inhibitor medications Current use of JAK inhibitor medications History of weight loss procedures including bariatric surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ISOThrive supplement 1<br>Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. | Dietary Supplement: ISOThrive Supplement<br>* Consumption of ISOThrive supplements for 3 months<br>|
| Active Comparator: ISOThrive supplement 2<br>Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. | Dietary Supplement: ISOThrive Supplement<br>* Consumption of ISOThrive supplements for 3 months<br>|
| Placebo Comparator: Placebo supplement<br>Participants assigned to the placebo supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period. | Dietary Supplement: Placebo Supplement<br>* Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Body weight will be measured at the beginning and at the end of the study using a calibrated digital scale. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger/satiety | will be assessed at the beginning and at the end of the study using a Visual Analog Scale (VAS) that will ask participants a series of questions to be completed at 2 time points: mid-morning between breakfast and lunch, and late evening between dinner and bed time. The VAS questions require participants to rate on a scale the strength of specific sensations they are feeling (i.e., hunger, thirst, amount of food they could eat right now, nausea, and fullness) by placing a vertical mark on the scale in response to each question. | Up to 12 weeks | 
| Satiety indicators | will be assessed at the beginning and end of the study with biological markers using Glucagon-like peptide-1 (GLP-1), PYY and ghrelin. | Up to 12 weeks | 
| Dietary intake data | Dietary intake will be assessed at the beginning and at the end of the study. Each participant will complete three 24-hour dietary recalls (two for weekdays, and one for a weekend day) using an online Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at http://riskfactor.cancer.gov/tools/instruments/asa24/). This data will be used to provide a representational measure of intake of kilocalories and macronutrients (protein, fat, and carbohydrates). | Up to 12 weeks | 
| Body mass index (BMI) | will be measured at the beginning and at the end of the study . BMI will be calculated as weight (kg) divided by height in meters (m) squared. Height will be measured by using a calibrated stadiometer. | Up to 12 weeks | 
| Body composition | will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. The Tanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 Body Composition Analyzer measures weight and calculates body fat percentage and total body water percentage in addition to BMI. Measures will be taken at baseline, 6 weeks and at the end of the 3-month intervention period. | Up to 12 weeks | 
| Leptin | Leptin levels will be used as a biomarker to monitor the amount of body fat. Leptin level will be assessed at the beginning and at the end of the study . Leptin is a hormone secreted exclusively by adipose cells in response to an increase in body fat mass, and is an important component in the regulation of long-term hunger and food intake. Leptin serves as the brain's indicator of the body's total energy stores. When leptin levels rise in the bloodstream they bind to receptors in arcuate nucleus (ARC). Leptin suppress the release of neuropeptide Y (NPY), which in turn prevents the release of appetite enhancing hypocretin (orexins) from the lateral hypothalamus. This decreases appetite and food intake, promoting weight loss. It also stimulates the expression of cocaine- and amphetamine-regulated transcript (CART). | Up to 12 weeks | 
| Waist circumference | will be measured at the beginning and end of the study using guidelines of the National Obesity Expert Panel Report. | Up to 12 weeks | 
| Blood pressure | will be measured by using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ) after sitting for 5 minutes. Both systolic and diastolic pressures will be calculated as the mean value of 2 readings 5 minutes apart for each participant at every time point of assessment. Blood pressure will be assessed at baseline, 6 weeks, and at the end of 3 months | Up to 12 weeks | 
| Homeostasis model assessment of insulin resistance (HOMA-IR) | will be measured in a fasting state at baseline and 12 weeks. Homeostasis model assessment of insulin resistance (HOMA-IR) values will be calculated from fasting serum glucose and serum insulin levels to gauge the degree of insulin resistance. | 12 weeks | 
| Blood Lipid levels | Total cholesterol (Tchol), triglycerides (TRIG), and high-density lipoprotein (HDL) will be obtained by direct measurements. Very-low-density lipoprotein (VLDL) and low-density-lipoprotein (LDL) are obtained by calculation: VLDL = TRIG/5; and LDL = Tchol - (VLDL + HDL). The HDL:Tchol ratio will be used to evaluate the impact of the supplement on lipid panel. The lipid profile will be assessed at baseline and at the end of 3 months. | Up to 12 weeks | 
| Abdominal symptoms | We will assess abdominal bloating, abdominal gas, and abdominal pain/discomfort at 6 weeks and at the end of 3 months. Abdominal symptoms will be assessed using a side effects survey. | 12 weeks | 
| Change in Quality of life | will be assessed using the SF-12 (http://www.sf-36.org/tools/sf12.shtml). The SF-12v2 Health Survey uses 12 questions to assess 8 domains of health and well-being (general health, physical function, physical role, bodily pain, mental health, emotional role, vitality, and social function) within the past 4 weeks. The SF-12v2 is a practical, reliable, and valid measure of physical and mental health and takes only 2 to 3 minutes to complete. This tool will be administered at baseline and at the end of 3 months. | Up to 12 weeks | 
| Liver function | will be assessed at baseline and at the end of 3 months via a comprehensive metabolic panel to explore the safety of the ISOThrive supplement. Liver function will be evaluated based on levels of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, and bilirubin. | Up to 12 weeks | 
| Kidney function | Kidney function will be evaluated using blood urea nitrogen and creatinine. | Up to 12 weeks | 
| Urine | Urine samples will be collected from participants at baseline and at the end of 3 months. Urinalysis will be used to detect substances or cellular material in the urine associated with different metabolic and kidney disorders. | Up to 12 weeks | 
| Complete blood count | will be performed to assess the different components of blood. | Up to 12 weeks | 
| Stool | The stool analysis will be done with samples taken for a subset of 40 subjects. DNA extraction (i.e. purification of DNA from sample), LH-PCR Fingerprinting (i.e to amplify a single copy or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence), and Multitag Pyrosequencing (i.e. determining the order of nucleotides in DNA based on the sequencing by synthesis principle) will be done with the collected stool at one week before the start of the intervention (i.e. one week before taking product), the day before the start of the intervention, and at the end of 3 months. | Up to 12 weeks | 
| Inflammatory biomarkers | High sensitivity C-reactive protein, TNF, IL6, IL10 and Interferon gamma will be used to monitor inflammation in our study participants. These biomarkers will be assessed at baseline and at the end of 3 months. | Up to 12 weeks | 
| Physical activity | Physical activity will be assessed at baseline and at the end of 3 months. PA will be assessed by the International Physical Activity Questionnaire (IPAQ).31 The IPAQ is a valid and reliable tool to assess physical activity in adults. It is a more comprehensive tool containing information on weekly activities in household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior. | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prebiotic, dietary supplement