Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00129792

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

MedlinePlus related topics: Cholesterol Dietary Supplements Metabolic Disorders Metabolic Syndrome Obesity Weight Control

Drug Information available for: Insulin Dextrose Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Cholesterol [ Time Frame: baseline, outcome ] [ Designated as safety issue: No ]
insulin function [ Time Frame: baseline, outcome ] [ Designated as safety issue: No ]
weight loss [ Time Frame: baseline, outcome ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cortisol levels [ Time Frame: baseline, outcome ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	July 2005
Estimated Study Completion Date:	January 2009
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Sham Comparator 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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Barry Oken, MD

Oregon Health and Science University

More Information

Responsible Party:	Helfgott Research Institute, NCNM ( Carlo Calabrese, ND )
Study ID Numbers:	U19 AT002656
Study First Received:	August 10, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00129792
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Blood Glucose
Cholesterol
Weight Loss
Insulin
Complementary Therapies

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Metabolic Syndrome X
Diabetes Mellitus
Prediabetic State
Endocrine System Diseases
Overweight
Insulin
Body Weight
Hyperinsulinism

Signs and Symptoms
Weight Loss
Syndrome X
Nutrition Disorders
Overnutrition
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009