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Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129792
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : October 29, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University

Tracking Information
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
 (submitted: June 27, 2011)
  • Cholesterol [ Time Frame: baseline (Week 1) and outcome (Week 12) ]
  • insulin function [ Time Frame: baseline (Week 1) and outcome (Week 12) ]
  • weight loss [ Time Frame: baseline (Week 1) and outcome (Week 12) ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
  • Cholesterol
  • insulin function
  • weight loss
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
Cortisol levels [ Time Frame: baseline (Week 1) and outcome (Week 12) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
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.

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
Condition  ICMJE
  • Metabolic Syndrome X
  • Prediabetic State
  • Insulin Resistance
  • Obesity
  • Metabolic Diseases
Intervention  ICMJE
  • Drug: Dietary supplement for weight loss
    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.
  • Behavioral: Education and counseling for weight loss
    Hour and a half weight loss education session weekly for 12 weeks.
Study Arms  ICMJE
  • Experimental: 1
    Has 100% expectation of receiving supplement
    Interventions:
    • Drug: Dietary supplement for weight loss
    • Behavioral: Education and counseling for weight loss
  • Sham Comparator: 2
    Has 50% expectation of receiving supplement
    Interventions:
    • Drug: Dietary supplement for weight loss
    • Behavioral: Education and counseling for weight loss
  • 3
    Has 0% expectation of receiving supplement.
    Intervention: Behavioral: Education and counseling for weight loss
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2008)
79
Original Enrollment  ICMJE
 (submitted: August 10, 2005)
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:

  • Body mass index (BMI) between 30 and 45
  • Live in the Portland, Oregon metropolitan area
  • Willing and able to complete a 12-week weight loss program
  • Meet at least 3 of the following 5 criteria: 1) waist circumference greater than 40 inches for men and 35 inches for women; 2) fasting triglycerides higher than 150 mg/dl; 3) high density lipoprotein (HDL) lower than 40 mg/dl for men and 50 mg/dl for women; 4) systolic blood pressure (BP) of 130 mmHg or higher or diastolic BP of 85 mmHg or higher; 5) fasting glucose of 100 mg/dl or higher

Exclusion Criteria:

  • Any medications, including dietary supplements, that could interfere with the study
  • Medical conditions contraindicating a diet and exercise weight loss program
  • History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic cardiovascular disease
  • Current diagnosis of cancer
  • Hospitalization for a psychiatric condition within 12 months prior to study entry
  • Weight loss medications within 6 months prior to study entry
  • Change in body weight greater than 5% within 6 months prior to study entry
  • Consumption of more than 21 alcoholic drinks per week
  • Current participation in another clinical trial OR living in the same household with another participant in this study
  • Currently exercising for more than 30 minutes, 3 times per week
  • Fasting blood glucose higher than 125 mg/dl
  • BP higher than 145/90
  • Triglycerides higher than 500 mg/dl
  • Training as a health care provider or health scientist
  • Pregnancy or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
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
Principal Investigator: Barry Oken, MD Oregon Health and Science University
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