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Obesity and type 2 diabetes have clearly been linked together and identified as epidemics in much of the developed world. Historically several different dietary fibers have been used as means of reducing body weight and the related development of type 2 diabetes. These studies have generated mixed, if not inconsistent, results suggesting that none of these fibers promise a solution to either of these two conditions. We are proposing to investigate the effects of including a new soluble fiber, a-cyclodextrin, FBCx® (to be called Y288 in this study), into the diet of adult overweight volunteers.
The overall aim is to investigate the effectiveness of a soluble dietary fiber, FBCx®, on weight loss and/or weight management, and blood lipid levels in overweight humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Subjects will fast prior to the initial visit. Subjects' weight, blood pressure and heart rate will be recorded, waist and hip circumferences measured, and body composition determined. They will receive either the soluble fiber or placebo tablets, in a coded bottle. They will be instructed to take 2 tablets per fat containing meal, 3 times a day within one hour of consuming the meal. They will also be asked to keep records of missed doses and any gastrointestinal symptoms (e.g.: heartburn, indigestion, diarrhea, constipation). During the 4th week, they will be asked to record food intakes for 3 days. After taking the supplement for 4 weeks, the participants will return to the clinic after an overnight fast. During this visit, they will turn in their 3-day dietary record. The studies performed during the initial baseline visit will be repeated. At this visit they receive the alternate supplement (placebo or active tablets) in a identical-looking coded bottle. |
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| 2 | Placebo Comparator | Subjects will fast prior to the initial visit. Subjects' weight, blood pressure and heart rate will be recorded, waist and hip circumferences measured, and body composition determined. They will receive either the soluble fiber or placebo tablets, in a coded bottle. They will be instructed to take 2 tablets per fat containing meal, 3 times a day within one hour of consuming the meal. They will also be asked to keep records of missed doses and any gastrointestinal symptoms (e.g.: heartburn, indigestion, diarrhea, constipation). During the 4th week, they will be asked to record food intakes for 3 days. After taking the supplement for 4 weeks, the participants will return to the clinic after an overnight fast. During this visit, they will turn in their 3-day dietary record. The studies performed during the initial baseline visit will be repeated. At this visit they receive the alternate supplement (placebo or active tablets) in a identical-looking coded bottle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y288 | Dietary Supplement | Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| without any altering of dietary habits or exercise routine, individuals shall lose or maintain body weight during the active phase as compared to the placebo phase. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood lipid levels during the active phase will be improved relative to the placebo phase. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sidika E Kasim-Karakas, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Y288 | Dietary Supplement | Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal |
|
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |