Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · May 25, 2010

Keywords

ClinConnect Summary

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 bil...

Gender

ALL

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.