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

• ClinicalTrials.gov Identifier: NCT00129792
• Recruitment Status: Completed
• First Posted: August 12, 2005
• Last Update Posted: October 29, 2014
• Sponsor: Oregon Health and Science University
• 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: August 10, 2005
• First Posted Date: August 12, 2005
• Last Update Posted Date: October 29, 2014
• Study Start Date: January 2005
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: August 10, 2005)

• Cholesterol
• insulin function
• weight loss

• Current Secondary Outcome Measures (submitted: June 27, 2011): Cortisol levels [ Time Frame: baseline (Week 1) and outcome (Week 12) ]
• Original Secondary Outcome Measures (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: Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Metabolic Syndrome X
• Prediabetic State
• Insulin Resistance
• Obesity
• Metabolic Diseases

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2008): 79
• Original Enrollment (submitted: August 10, 2005): 100
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 21 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00129792
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Barry S. Oken, Oregon Health and Science University
• Study Sponsor: Oregon Health and Science University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Barry Oken, MD; Oregon Health and Science University

• PRS Account: Oregon Health and Science University
• Verification Date: October 2014