Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

The purpose of this 2-stage intervention study is to investigate the effect of a novel nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and weight loss maintenance in obese participants.

Key facts

Study ID

NCT01656681

Run by

MetaProteomics LLC

People needed

130

Starts

2011-05-01

Expected to finish

2012-12-01

Last updated by the study team

2018-05-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI ≥ 30 and ≤ 47

You may not qualify if…

• Prohibited medications, supplements or herbal products
• Use of narcotics, oral or injectable corticosteroids, multivitamin/multimineral supplements, antioxidant supplements, vitamin D supplements, probiotics and omega-3 fatty acid supplements 30 days prior to screening and for the duration of the study.
• Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
• Change in prescription, OTC, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
• Medical history and concurrent diseases
• Known allergy or hypersensitivity to study product or placebo.
• Clinically significant abnormalities in medical history of physical examination.
• Clinically relevant conditions expected to preclude achievement of exercise recommendation.
• Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
• Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, TB ,hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness.
• Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study.
• Use of drugs of abuse (e.g. marijuana, cocaine, PCP, and methamphetamine) within 30 days prior to screening and for the duration of the study.
• Other criteria
• Initiation of a new or change of an existing exercise regiment within 30 days prior to screening.
• Initiation of a new or change of an existing food plan within 30 days prior to screening.

Where it is running

• Functional Medicine Research Center — Gig Harbor, Washington, United States

Full record on ClinicalTrials.gov

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