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

NCT ID: NCT01656681

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

THIAA

Intervention Type: DIETARY_SUPPLEMENT

A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day

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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablet

Interventions

THIAA

A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo tablet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MetaProteomics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph J Lamb, MD

Role: PRINCIPAL_INVESTIGATOR

MetaProteomics / Metagenics

Locations

Functional Medicine Research Center

Gig Harbor, Washington, United States

Countries

United States

Other Identifiers

WLM1-FMR-CT

Identifier Type: -

Identifier Source: org_study_id