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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: THIAA; Dietary Supplement: Placebo

• Registration Number: NCT01656681
• Lead Sponsor: MetaProteomics LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THIAA	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (1)

Functional Medicine Research Center; 🇺🇸 Gig Harbor, Washington, United States