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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656681
• Other study ID #: WLM1-FMR-CT
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2018
• Source: MetaProteomics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• THIAA
A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	Functional Medicine Research Center	Gig Harbor	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MetaProteomics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight loss	Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).	Baseline, 12 weeks
Secondary	Weight loss	Absolute amount of weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).	Baseline, 12 weeks
Secondary	Short-term THIAA effect	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).	Baseline, 12 weeks
Secondary	Short-term THIAA effect	Comparing the difference in percent weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial).	Baseline, 12 weeks
Secondary	Weight loss	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).	12 weeks, 64 weeks
Secondary	Weight loss	To evaluate percent weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks).	12 weeks, 64 weeks
Secondary	Long-term THIAA effect	To evaluate the difference between 2 arms the amount of weight loss during the trial (i.e. baseline to 64 weeks).	baseline, 64 weeks