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

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02501356

Run by

Griffin Hospital

People needed

103

Starts

2015-04-01

Expected to finish

2015-11-01

Last updated by the study team

2020-03-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI of 25 and over and weight not > 350lb
• Age between 18 and 75
• Non-smokers
• Able to read and write in English

You may not qualify if…

• 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

Where it is running

• Yale-Griffin Prevention Research Center — Derby, Connecticut, United States

Full record on ClinicalTrials.gov

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