Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

This single center, double-blinded, cross-over, placebo controlled clinical pilot study will investigate the effectiveness of a soluble dietary fiber, alpha-cyclodextrin (alpha-CD), on blood lipid and lipoprotein levels in healthy human subjects. alpha-CD, a cyclical polymer of glucose, is currently sold as an over the counter food supplement and is a common ingredient in many foods. This is the first study that will evaluate the effect of alpha-CD in healthy subjects. One gram of alpha-CD has been shown to bind as much as 9 grams of dietary fat, and like other soluble dietary fibers or bile acid sequestrants (BAS) it may decrease the intestinal absorption of fats, which has been shown to reduce the incidence of cardiovascular disease (CVD). Animal studies in our laboratory have shown that oral alpha-CD lowers Low Density Lipoprotein-cholesterol (LDL-C) by approximately 15 percent in mice on a high fat diet. Other clinical trials utilizing this compound showed that it is a safe therapy with no significant side effects.

Eligibility:

• Individuals between 18 and 75 years of age who do not have type 1 or type 2 diabetes.

Design:

• This study will require three visits to the NIH Clinical Center.
• At the first visit, participants will provide information about current diet and exercise routines, and will have a physical examination with blood and urine tests. At the end of this visit, participants will be randomized to receive either Alpha-CD or placebo, and will be asked to take two 1 gram tablets three times a day, anytime from 1 hour before to the end of each meal. Participants will take a total of six tablets per day for 12 weeks.
• At the end of the first 12 weeks, participants will return to the clinical center for another interview and examination, and blood and urine tests. At the end of this visit, participants will receive the treatment not given in the first part of the study (either Alpha-CD or placebo), and will take tablets on the same schedule as before for 12 more weeks.
• Participants will wait for 1 week after stopping the previous study prescription before starting the next one.
• At the end of the second 12 weeks, participants will have a final interview and examination with blood and urine tests.
• Participants will be asked to keep 7-day food records before each clinic visit to be collected at the second and third visits. A short physical activity assessment will be collected at each visit to review any changes in physical activity.