The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

Conditions
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Obesity, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Alpha-cyclodextrin and digestible starch
* Dietary Supplement: Alpha-cyclodextrin
* Dietary Supplement: Digestible starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 20 and 30 kg/m2 inclusive Weight ≥ 65 kg for females, and ≥ 55 kg for males Exclusion Criteria: Pregnant or nursing. Diabetes Mellitus Any medication to reduce lipids History of gastrointestinal surgery, except for cholecystectomy or appendectomy History of malabsorption

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-cyclodextrin and digestible starch<br>Supplementation with three grams alpha cyclodextrin with three grams of digestible starch | Dietary Supplement: Alpha-cyclodextrin<br>* Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin<br>|
| Experimental: Alpha-cyclodextrin<br>Supplementation with six grams of alpha-cyclodextrin | Dietary Supplement: Alpha-cyclodextrin and digestible starch<br>* Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch<br>|
| Placebo Comparator: Digestible Starch<br>Supplementation with six grams of digestible starch | Dietary Supplement: Digestible starch<br>* Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha-cyclodextrin, Dietary fiber, Fecal fat, Saturated fat