Condition(s) treated: Metabolic Syndrome X; Prediabetic State; Insulin Resistance; Obesity; Metabolic Diseases

Intervention: Dietary supplement for weight loss (Drug); Education and counseling for weight loss (Behavior)

Enrollment status: Recruiting. Expecting to enroll 100 people.

Sponsor: National Center for Complementary and Alternative Medicine (NCCAM)

Principal investigator(s) or official(s):
Barry Oken, MD, Principal Investigator, Affiliation: Oregon Health and Science University

Overall contact:
Erin Connelly, Phone: 503-552-1744, Email: econnelly@ncnm.edu

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.

Official title: Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome

Study design: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Cholesterol; insulin function; weight loss

Secondary outcome: Cortisol levels

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.

Minimum eligible age: 21 Years. Maximum eligible age: 60 Years. Eligible gender(s): Both.

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

Erin Connelly, Phone: 503-552-1744, Email: econnelly@ncnm.edu

Oregon Health and Science University General Clinical Research Center, Portland, Oregon 97239, United States; Recruiting
Erin Connelly, Phone: 503-552-1744, Email: econnelly@ncnm.edu
Jon Purnell, MD, Sub-Investigator

Start date: July 2005
End date: August 2007
Last updated: September 28, 2006