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

Primary Purpose

Metabolic Syndrome X, Prediabetic State, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary supplement for weight loss
Education and counseling for weight loss
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Blood Glucose, Cholesterol, Weight Loss, Insulin, Complementary Therapies

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health and Science University General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

1

2

3

Arm Description

Has 100% expectation of receiving supplement

Has 50% expectation of receiving supplement

Has 0% expectation of receiving supplement.

Outcomes

Primary Outcome Measures

Cholesterol
insulin function
weight loss

Secondary Outcome Measures

Cortisol levels

Full Information

First Posted
August 10, 2005
Last Updated
October 27, 2014
Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00129792
Brief Title
Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Official Title
Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Prediabetic State, Insulin Resistance, Obesity, Metabolic Diseases
Keywords
Blood Glucose, Cholesterol, Weight Loss, Insulin, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Has 100% expectation of receiving supplement
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Has 50% expectation of receiving supplement
Arm Title
3
Arm Type
Other
Arm Description
Has 0% expectation of receiving supplement.
Intervention Type
Drug
Intervention Name(s)
Dietary supplement for weight loss
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education and counseling for weight loss
Intervention Description
Hour and a half weight loss education session weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Cholesterol
Time Frame
baseline (Week 1) and outcome (Week 12)
Title
insulin function
Time Frame
baseline (Week 1) and outcome (Week 12)
Title
weight loss
Time Frame
baseline (Week 1) and outcome (Week 12)
Secondary Outcome Measure Information:
Title
Cortisol levels
Time Frame
baseline (Week 1) and outcome (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Oken, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University General Clinical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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