Clinical trial NCT02501356: Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults
Official title: Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: prebiotic
dietary supplement
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: ISOThrive Inc.
First posted: 2015-07-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Hunger/satiety
timeFrame: Up to 12 weeks
measure: Satiety indicators
timeFrame: Up to 12 weeks
measure: Dietary intake data
timeFrame: Up to 12 weeks
measure: Body mass index (BMI)
timeFrame: Up to 12 weeks
measure: Body composition
timeFrame: Up to 12 weeks
measure: Leptin
timeFrame: Up to 12 weeks
measure: Waist circumference
timeFrame: Up to 12 weeks
measure: Blood pressure
timeFrame: Up to 12 weeks
measure: Homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 12 weeks
measure: Blood Lipid levels
timeFrame: Up to 12 weeks
measure: Abdominal symptoms
timeFrame: 12 weeks
measure: Change in Quality of life
timeFrame: Up to 12 weeks
measure: Liver function
timeFrame: Up to 12 weeks
measure: Kidney function
timeFrame: Up to 12 weeks
measure: Urine
timeFrame: Up to 12 weeks
measure: Complete blood count
timeFrame: Up to 12 weeks
measure: Stool
timeFrame: Up to 12 weeks
measure: Inflammatory biomarkers
timeFrame: Up to 12 weeks
measure: Physical activity
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale-Griffin Prevention Research Center
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: David L. Katz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale-Griffin Prevention Research Center
name: Valentine Y. Njike, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: