Clinical trial NCT01131299
Conditions: Cardiovascular Disease
Keywords: HDL Cholesterol Lipoproteins Serum Lipids Alpha-Cyclodextrin Atherosclerosis Heart Disease
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Start date: 2010-03-01; Completion date: 2015-02-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Background:

* Cardiovascular disease (CVD) is a leading cause of death in developed countries. Although statin-type drugs are currently the most effective therapeutic agents for reducing CVD risk. One possible complementary approach involves the use of soluble dietary fibers that are known to reduce blood cholesterol levels. However, analysis has shown that most soluble fibers reduce total cholesterol levels by relatively small amounts.
* Alpha-Cyclodextrin (Alpha-CD), also sold in commerical form, is a soluble fiber derived from corn that is used as an ingredient in many foods, such as bread rolls, crackers, juices, and reduced fat spreads. It is added to food primarily as a fiber supplement but is also used to stabilize flavors, colors, vitamins, and fatty acids. Studies in animals and humans have shown that Alpha-CD may help to improve insulin resistance and lower LDL cholesterol levels with no apparent side effects. More research is needed to determine the effect of Alpha-CD on total cholesterol levels in healthy volunteers.

Objectives:

\- To determine the effect of oral Alpha-CD on total cholesterol in a nondiabetic population.

Detailed description:
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.

Arms: arm 1: Randomized subjects will receive alpha cyclodextrin 2g orally three times a day for 12-14 weeks. After the one week washout, the subjects will receive 2 tablets orally of placebo (three times a day for 12-14 weeks). arm 2: Participants will receive 2 tablets orally of placebo (three times a day for 12-14 weeks). The subjects will have a one-week washout. After the washout, the participants will receive alpha cyclodextrin 2g orally three times a day for 12-14 weeks.
Interventions: intervention 1: Placebo intervention 2: Alpha cyclodextrin
Intervention descriptions: intervention 1: 2 tablets PO 3 times a day for 12-14 weeks intervention 2: 2g PO 3 times a day for 12-14 weeks

Protocol documents: