Back to resultsEffect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THIAA
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 30 and ≤ 47
Exclusion Criteria:
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.
Sites / Locations
- Functional Medicine Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
THIAA
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Weight loss maintenance
The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.
Secondary Outcome Measures
Weight loss
Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01656681
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MetaProteomics LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THIAA
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
THIAA
Intervention Description
A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Weight loss maintenance
Description
The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.
Time Frame
Baseline, 64 weeks
Secondary Outcome Measure Information:
Title
Weight loss
Description
Percent weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
Time Frame
Baseline, 12 weeks
Title
Weight loss
Description
Absolute amount of weight loss at the end of 12 weeks (i.e. the Stage 1 of the trial where subjects participate in HP2).
Time Frame
Baseline, 12 weeks
Title
Short-term THIAA effect
Description
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).
Time Frame
Baseline, 12 weeks
Title
Short-term THIAA effect
Description
Comparing the difference in percent weight loss between 2 arms at the end of 12 weeks (i.e. the Stage 1 of the trial).
Time Frame
Baseline, 12 weeks
Title
Weight loss
Description
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).
Time Frame
12 weeks, 64 weeks
Title
Weight loss
Description
To evaluate percent weight loss during Stage 2 of the trial where subjects participate in MLGL (i.e. 12 weeks to 64 weeks).
Time Frame
12 weeks, 64 weeks
Title
Long-term THIAA effect
Description
To evaluate the difference between 2 arms the amount of weight loss during the trial (i.e. baseline to 64 weeks).
Time Frame
baseline, 64 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI ≥ 30 and ≤ 47
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Lamb, MD
Organizational Affiliation
MetaProteomics / Metagenics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Functional Medicine Research Center
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98332
Country
United States
12. IPD Sharing Statement
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Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects
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