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

NCT ID: NCT02501356

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-11-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ISOThrive supplement 1

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.

Group Type: ACTIVE_COMPARATOR

ISOThrive Supplement

Intervention Type: DIETARY_SUPPLEMENT

Consumption of ISOThrive supplements for 3 months

ISOThrive supplement 2

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.

Group Type: ACTIVE_COMPARATOR

ISOThrive Supplement

Intervention Type: DIETARY_SUPPLEMENT

Consumption of ISOThrive supplements for 3 months

Placebo supplement

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.

Group Type: PLACEBO_COMPARATOR

Placebo Supplement

Intervention Type: DIETARY_SUPPLEMENT

Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months

Interventions

ISOThrive Supplement

Consumption of ISOThrive supplements for 3 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo Supplement

Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months

Intervention Type: DIETARY_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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ISOThrive Inc.

INDUSTRY

Sponsor Role: collaborator

Griffin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L. Katz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Valentine Y. Njike, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Locations

Yale-Griffin Prevention Research Center

Derby, Connecticut, United States

Countries

United States

Other Identifiers

2014-09

Identifier Type: -

Identifier Source: org_study_id