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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by MetaProteomics LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
MetaProteomics LLC
ClinicalTrials.gov Identifier:
NCT01656681
First received: August 1, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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 Intervention
Obesity
Dietary Supplement: THIAA
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A 64-week Pilot Trial to Evaluate the Effects of a Novel Nutraceutical on Weight Loss and Weight Loss Maintenance in Obese Subjects

Resource links provided by NLM:


Further study details as provided by MetaProteomics LLC:

Primary Outcome Measures:
  • Weight loss maintenance [ Time Frame: Baseline, 64 weeks ] [ Designated as safety issue: No ]
    The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.


Secondary Outcome Measures:
  • Weight loss [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).

  • Weight loss [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks, 64 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks, 64 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    To evaluate the difference between 2 arms the amount of weight loss during the trial (i.e. baseline to 64 weeks).


Estimated Enrollment: 124
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656681

Locations
United States, Washington
Functional Medicine Research Center
Gig Harbor, Washington, United States, 98332
Sponsors and Collaborators
MetaProteomics LLC
Investigators
Principal Investigator: Joseph J Lamb, MD MetaProteomics / Metagenics
  More Information

No publications provided

Responsible Party: MetaProteomics LLC
ClinicalTrials.gov Identifier: NCT01656681     History of Changes
Other Study ID Numbers: WLM1-FMR-CT
Study First Received: August 1, 2012
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014