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

MetaProteomics

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: THIAA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656681

WLM1-FMR-CT

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

THIAA

Experimental group

Description:

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.

Treatment:

Dietary Supplement: THIAA

Placebo

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo