Overview

This trial is active, not recruiting.

Condition obesity
Treatments thiaa, placebo
Sponsor MetaProteomics LLC
Start date May 2011
End date November 2012
Trial size 124 participants
Trial identifier NCT01656681, WLM1-FMR-CT

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Experimental)
Stage 1 (the first 12 weeks of the study): all subjects participate in a structured lifestyle change program featuring a high-protein, high-phytonutrient food plan (HP2). Those randomized to THIAA arm additionally receive the THIAA tablet, 3 times a day. Stage 2 (the subsequent 52-week study): All qualified subjects (i.e. those who have lost at least 7.5% of their body weight in Stage 1) participate in a less restrictive lifestyle change program featuring a Mediterranean-style Low-glycemic-load food plan (MLGL). Those randomized to THIAA arm additionally receive the THIAA tablet, 3 times a day.
thiaa
A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
(Active Comparator)
Stage 1 (the first 12 weeks of the study): all subjects participate in a structured lifestyle change program featuring a high-protein, high-phytonutrient food plan (HP2). Those randomized to Placebo arm receive the placebo tablet, 3 times a day. Stage 2 (the subsequent 52-week study): All qualified subjects (i.e. those who have lost at least 7.5% of their body weight in Stage 1) participate in a less restrictive lifestyle change program featuring a Mediterranean-style Low-glycemic-load food plan (MLGL). Those randomized to Placebo arm receive the placebo tablet, 3 times a day.
placebo
Placebo tablet

Primary Outcomes

Measure
Weight loss maintenance
time frame: Baseline, 64 weeks

Secondary Outcomes

Measure
Weight loss
time frame: Baseline, 12 weeks
Weight loss
time frame: Baseline, 12 weeks
Short-term THIAA effect
time frame: Baseline, 12 weeks
Short-term THIAA effect
time frame: Baseline, 12 weeks
Weight loss
time frame: 12 weeks, 64 weeks
Weight loss
time frame: 12 weeks, 64 weeks
Long-term THIAA effect
time frame: baseline, 64 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - BMI ≥ 30 and ≤ 47 Exclusion Criteria: - Prohibited medications, supplements or herbal products 1. 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. 2. Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss. 3. 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 1. Known allergy or hypersensitivity to study product or placebo. 2. Clinically significant abnormalities in medical history of physical examination. 3. Clinically relevant conditions expected to preclude achievement of exercise recommendation. 4. Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease. 5. 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. 6. Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study. 7. 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 1. Initiation of a new or change of an existing exercise regiment within 30 days prior to screening. 2. Initiation of a new or change of an existing food plan within 30 days prior to screening.

Additional Information

Official title A 64-week Pilot Trial to Evaluate the Effects of a Novel Nutraceutical on Weight Loss and Weight Loss Maintenance in Obese Subjects
Principal investigator Joseph J Lamb, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by MetaProteomics LLC.