NCT00129792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

August 10, 2005

Last Update Submit

October 27, 2014

Conditions

Metabolic Syndrome XPrediabetic StateInsulin ResistanceObesityMetabolic Diseases

Keywords

Blood GlucoseCholesterolWeight LossInsulinComplementary Therapies

Outcome Measures

Primary Outcomes (3)

  • Cholesterol

    baseline (Week 1) and outcome (Week 12)

  • insulin function

    baseline (Week 1) and outcome (Week 12)

  • weight loss

    baseline (Week 1) and outcome (Week 12)

Secondary Outcomes (1)

  • Cortisol levels

    baseline (Week 1) and outcome (Week 12)

Study Arms (3)

1

EXPERIMENTAL

Has 100% expectation of receiving supplement

Drug: Dietary supplement for weight lossBehavioral: Education and counseling for weight loss

2

SHAM COMPARATOR

Has 50% expectation of receiving supplement

Drug: Dietary supplement for weight lossBehavioral: Education and counseling for weight loss

3

OTHER

Has 0% expectation of receiving supplement.

Behavioral: Education and counseling for weight loss

Interventions

Dietary supplement for weight lossDRUG

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.

12
Education and counseling for weight lossBEHAVIORAL

Hour and a half weight loss education session weekly for 12 weeks.

123

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University General Clinical Research Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Metabolic SyndromePrediabetic StateInsulin ResistanceObesityMetabolic DiseasesWeight Loss

Interventions

Dietary SupplementsEducational StatusCounseling

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSocioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Barry Oken, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 10, 2005

First Posted

August 12, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2007

Study Completion

April 1, 2014

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

US(1)