Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: THIAA 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. |
Dietary Supplement: THIAA
A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
|
| Active Comparator: Placebo 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. |
Dietary Supplement: Placebo
Placebo tablet
|
Outcome Measures
Primary Outcome Measures
- Weight loss maintenance [Baseline, 64 weeks]
The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.
Secondary Outcome Measures
- Weight loss [Baseline, 12 weeks]
Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
- Weight loss [Baseline, 12 weeks]
Absolute amount of weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
- Short-term THIAA effect [Baseline, 12 weeks]
Comparing the difference in absolute amount of weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial).
- Short-term THIAA effect [Baseline, 12 weeks]
Comparing the difference in percent weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial).
- Weight loss [12 weeks, 64 weeks]
To evaluate absolute amount of weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks).
- Weight loss [12 weeks, 64 weeks]
To evaluate percent weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks).
- Long-term THIAA effect [baseline, 64 weeks]
To evaluate the difference between 2 arms the amount of weight loss during the trial (i.e. baseline to 64 weeks).
Eligibility Criteria
Criteria
Inclusion Criteria:
- BMI ≥ 30 and ≤ 47
Exclusion Criteria:
- Prohibited medications, supplements or herbal products
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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.
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Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
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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
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Known allergy or hypersensitivity to study product or placebo.
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Clinically significant abnormalities in medical history of physical examination.
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Clinically relevant conditions expected to preclude achievement of exercise recommendation.
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Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
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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.
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Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study.
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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
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Initiation of a new or change of an existing exercise regiment within 30 days prior to screening.
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Initiation of a new or change of an existing food plan within 30 days prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Functional Medicine Research Center | Gig Harbor | Washington | United States | 98332 |
Sponsors and Collaborators
- MetaProteomics LLC
Investigators
- Principal Investigator: Joseph J Lamb, MD, MetaProteomics / Metagenics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WLM1-FMR-CT