Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Placebo; Alpha cyclodextrin
Intervention type(s): Other; Drug
Intervention description(s): 2 tablets PO 3 times a day for 12-14 weeks; 2g PO 3 times a day for 12-14 weeks
Other intervention name(s): alpha- CD; Alpha-CD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HDL; Cholesterol; Lipoproteins; Serum Lipids; Alpha-Cyclodextrin; Atherosclerosis; Heart Disease