Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Placebo; Alpha cyclodextrin
Intervention description: 2 tablets PO 3 times a day for 12-14 weeks; 2g PO 3 times a day for 12-14 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HDL; Cholesterol; Lipoproteins; Serum Lipids; Alpha-Cyclodextrin; Atherosclerosis; Heart Disease

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Males and females between the ages of 18-75.

        Subject understands protocol and provides written, informed consent in addition to a
        willingness to comply with specified follow-up evaluations.

        EXCLUSION CRITERIA:

          -  Pregnancy or women currently breastfeeding.

          -  BMI less than 18.5

          -  Subjects with unstable weight that varies greater than 10% over the past 3 months.

          -  Subjects currently following any low-fat (< 20%) diet.

          -  Subjects that routinely consume less than 3 meals/snacks per day

          -  Subjects taking the following medications, which may show reduced absorption with
             alpha-CD or may otherwise interfere with the study will be excluded: soluble fiber
             supplements, BAS, plant sterol supplements, antibiotics, anticoagulants,
             anticonvulsants, antiarrhythmics , cyclosporine, mycophenolate, synthroid, vitamin A,
             E and K and or any drug that is necessary to take with a meal. If any of these
             medications are initiated during the study, the subjects will be instructed to
             discontinue the use of the alpha-CD or placebo pills and to withdraw from the study.
             Short-term and prophylactic antibiotics may be taken during study participation for up
             to 14 days, at least 2 hours apart from the study drug.

          -  Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel
             motility problems, or other conditions that could affect intestinal fat absorption.

          -  Subjects initiating new medications or patients on multiple medications may also be
             excluded.

          -  Patients with type I or type II diabetes.

          -  Subjects currently taking alpha-CD in its commercial form.

          -  Volunteers may also be excluded, if in the opinion of the study investigators, they
             have some other condition or disorder that may adversely affect the outcome of the
             study or the safety of the volunteer.