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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00129792
First received: August 10, 2005
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome X
Prediabetic State
Insulin Resistance
Obesity
Metabolic Diseases
Drug: Dietary supplement for weight loss
Behavioral: Education and counseling for weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Cholesterol [ Time Frame: baseline (Week 1) and outcome (Week 12) ] [ Designated as safety issue: No ]
  • insulin function [ Time Frame: baseline (Week 1) and outcome (Week 12) ] [ Designated as safety issue: No ]
  • weight loss [ Time Frame: baseline (Week 1) and outcome (Week 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol levels [ Time Frame: baseline (Week 1) and outcome (Week 12) ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: January 2005
Estimated Study Completion Date: May 2014
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Has 100% expectation of receiving supplement
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.
Sham Comparator: 2
Has 50% expectation of receiving supplement
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.
3
Has 0% expectation of receiving supplement.
Behavioral: Education and counseling for weight loss
Hour and a half weight loss education session weekly for 12 weeks.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129792

Locations
United States, Oregon
Oregon Health and Science University General Clinical Research Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Barry Oken, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Barry S. Oken, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00129792     History of Changes
Other Study ID Numbers: U19 AT002656, U19AT002656-03, U19AT002656-02, U19AT002656
Study First Received: August 10, 2005
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
Blood Glucose
Cholesterol
Weight Loss
Insulin
Complementary Therapies

Additional relevant MeSH terms:
Insulin Resistance
Metabolic Diseases
Obesity
Prediabetic State
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014