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

Study Overview
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Brief Summary
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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.

Official Title
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A 64-week Pilot Trial to Evaluate the Effects of a Novel Nutraceutical on Weight Loss and Weight Loss Maintenance in Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: THIAA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 30 and ≤ 47 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THIAA<br>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<br>* A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day<br>|
| Active Comparator: Placebo<br>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<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss maintenance | The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks. | Baseline, 64 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2). | Baseline, 12 weeks | 
| Weight loss | Absolute amount of weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2). | Baseline, 12 weeks | 
| Short-term THIAA effect | 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). | Baseline, 12 weeks | 
| Short-term THIAA effect | Comparing the difference in percent weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial). | Baseline, 12 weeks | 
| Weight loss | 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). | 12 weeks, 64 weeks | 
| Weight loss | To evaluate percent weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks). | 12 weeks, 64 weeks | 
| Long-term THIAA effect | To evaluate the difference between 2 arms the amount of weight loss during the trial (i.e. baseline to 64 weeks). | baseline, 64 weeks |