Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT00129792 |
Recruitment Status :
Completed
First Posted : August 12, 2005
Last Update Posted : October 29, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | August 10, 2005 | |||
First Posted Date ICMJE | August 12, 2005 | |||
Last Update Posted Date | October 29, 2014 | |||
Study Start Date ICMJE | January 2005 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Cortisol levels [ Time Frame: baseline (Week 1) and outcome (Week 12) ] | |||
Original Secondary Outcome Measures ICMJE |
Cortisol levels | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome | |||
Official Title ICMJE | Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome | |||
Brief Summary | This study will determine the effects of a supplement in reducing symptoms of metabolic syndrome, a collection of symptoms that increase the risk for developing heart disease, stroke, and diabetes. | |||
Detailed Description | Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity; these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease and diabetes. The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function. This study will last 12 weeks. Participants will be randomly assigned to one of three arms. Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50% chance of receiving either the supplement or placebo; participants in Arm 3 will receive placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after the follow-up visit. Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin, cholesterol, and levels of certain hormones. Participants will also be asked to complete questionnaires at study entry and at Week 12; the questionnaires will assess depression, stress, self-absorption, optimism, food cravings, hunger, the degree to which participants seek pleasure from activities, and participants' thoughts about their ability to make behavioral changes. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
79 | |||
Original Enrollment ICMJE |
100 | |||
Actual Study Completion Date ICMJE | April 2014 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00129792 | |||
Other Study ID Numbers ICMJE | U19AT002656( U.S. NIH Grant/Contract ) U19AT002656-03 ( U.S. NIH Grant/Contract ) U19AT002656-02 ( U.S. NIH Grant/Contract ) U19AT002656 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Barry S. Oken, Oregon Health and Science University | |||
Study Sponsor ICMJE | Oregon Health and Science University | |||
Collaborators ICMJE | National Center for Complementary and Integrative Health (NCCIH) | |||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |