Clinical trial NCT01656681: Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: MetaProteomics LLC
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Weight loss maintenance
timeFrame: Baseline, 64 weeks
Secondary outcomes:
measure: Weight loss
timeFrame: Baseline, 12 weeks
measure: Weight loss
timeFrame: Baseline, 12 weeks
measure: Short-term THIAA effect
timeFrame: Baseline, 12 weeks
measure: Short-term THIAA effect
timeFrame: Baseline, 12 weeks
measure: Weight loss
timeFrame: 12 weeks, 64 weeks
measure: Weight loss
timeFrame: 12 weeks, 64 weeks
measure: Long-term THIAA effect
timeFrame: baseline, 64 weeks
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Functional Medicine Research Center
state: Washington
Study officials:
affiliation: MetaProteomics / Metagenics
name: Joseph J Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References: