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

Obesity Clinical Trial

Official title:

Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129792
• Other study ID #: U19AT002656
• Secondary ID: U19AT002656-03U1
• Status: Completed
• Phase: N/A
• First received: August 10, 2005
• Last updated: October 27, 2014
• Start date: January 2005
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 2014
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University General Clinical Research Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol		baseline (Week 1) and outcome (Week 12)	No
Primary	insulin function		baseline (Week 1) and outcome (Week 12)	No
Primary	weight loss		baseline (Week 1) and outcome (Week 12)	No
Secondary	Cortisol levels		baseline (Week 1) and outcome (Week 12)	No