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| Name | Class |
|---|---|
| Quest Nutrition LLC | UNKNOWN |
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Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control
Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-cyclodextrin and digestible starch | Active Comparator | Supplementation with three grams alpha cyclodextrin with three grams of digestible starch |
|
| Alpha-cyclodextrin | Experimental | Supplementation with six grams of alpha-cyclodextrin |
|
| Digestible Starch | Placebo Comparator | Supplementation with six grams of digestible starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-cyclodextrin and digestible starch | Dietary Supplement | Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Fat Excretion compared at three time periods. | Each subject will consume a different product every six consecutive days which is called a feeding period. On the fourth, fifth, and sixth day of each feeding period, a comparison of fat excretion will be measured through a stool sample. These feeding periods will occur for three consecutive six days totaling eighteen days of feeding. 6+6+6=18 | Assessment of change at each fourth, fifth, and sixth day of each feeding period. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Subjects will be asked if they experienced any adverse events. All adverse events will be recorded and evaluated. | The duration of the 18 days in the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank L Greenway, M.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21127475 | Background | Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2. | |
| 17013969 | Background | Grunberger G, Jen KL, Artiss JD. The benefits of early intervention in obese diabetic patients with FBCx: a new dietary fibre. Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. doi: 10.1002/dmrr.687. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C032613 | alpha-cyclodextrin |
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| Alpha-cyclodextrin | Dietary Supplement | Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin |
|
| Digestible starch | Dietary Supplement | Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch |
|
| 16423626 | Background | Artiss JD, Brogan K, Brucal M, Moghaddam M, Jen KL. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism. 2006 Feb;55(2):195-202. doi: 10.1016/j.metabol.2005.08.012. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |