Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTTHIAA
A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
DIETARY_SUPPLEMENTPlacebo
Placebo tablet
Sponsors
MetaProteomics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
Countries
United States
Outcome results
None listed