Cardiovascular Disease, Obesity
Conditions
Keywords
Alpha-cyclodextrin, Dietary fiber, Fecal fat, Saturated fat
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTAlpha-cyclodextrin and digestible starch
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch
DIETARY_SUPPLEMENTAlpha-cyclodextrin
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
DIETARY_SUPPLEMENTDigestible starch
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch
Sponsors
Quest Nutrition LLC
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Fat Excretion compared at three time periods. | Assessment of change at each fourth, fifth, and sixth day of each feeding period. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | The duration of the 18 days in the study. | Subjects will be asked if they experienced any adverse events. All adverse events will be recorded and evaluated. |
Countries
United States
Outcome results
None listed