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| ID | Type | Description | Link |
|---|---|---|---|
| U19AT002656-03 | U.S. NIH Grant/Contract | View source | |
| U19AT002656-02 | U.S. NIH Grant/Contract | View source | |
| U19AT002656 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Has 100% expectation of receiving supplement |
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| 2 | Sham Comparator | Has 50% expectation of receiving supplement |
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| 3 | Other | Has 0% expectation of receiving supplement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement for weight loss | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol levels | baseline (Week 1) and outcome (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry Oken, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University General Clinical Research Center | Portland | Oregon | 97239 | United States |
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| Education and counseling for weight loss | Behavioral | Hour and a half weight loss education session weekly for 12 weeks. |
|
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D004522 | Educational Status |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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