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

NCT01656681 | Completed

• 1 other identifier: WLM1-FMR-CT
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Weight loss maintenance

  The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.

  Baseline, 64 weeks

Secondary Outcomes (7)

• Weight loss

  Baseline, 12 weeks

• Weight loss

  Baseline, 12 weeks

• Short-term THIAA effect

  Baseline, 12 weeks

• Short-term THIAA effect

  Baseline, 12 weeks

• Weight loss

  12 weeks, 64 weeks

Study Arms (2)

THIAA

EXPERIMENTAL

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

Placebo

ACTIVE COMPARATOR

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

Interventions

THIAA DIETARY_SUPPLEMENT

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

THIAA

Placebo DIETARY_SUPPLEMENT

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 30 and ≤ 47

You may not qualify if:

• Prohibited medications, supplements or herbal products
• 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.
• Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
• 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
• Known allergy or hypersensitivity to study product or placebo.
• Clinically significant abnormalities in medical history of physical examination.
• Clinically relevant conditions expected to preclude achievement of exercise recommendation.
• Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
• 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.
• Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study.
• 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
• Initiation of a new or change of an existing exercise regiment within 30 days prior to screening.
• Initiation of a new or change of an existing food plan within 30 days prior to screening.

Sponsors & Collaborators

• MetaProteomics LLC: lead

Study Sites (1)

Functional Medicine Research Center

Gig Harbor, Washington, 98332, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph J Lamb, MD

  MetaProteomics / Metagenics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 3, 2012
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

US (1)