Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01131299
First received: May 25, 2010
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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:

- 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.

Condition Intervention Phase
Cardiovascular Disease
Other: Placebo
Drug: Alpha-CD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Determine the effect of oral Alpha-CD on total cholesterol in a healthy population. [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any changes in body weight and fasting glucose. [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Randomized subjects receiveing active comparator
Drug: Alpha-CD
2g PO 3 times a day for 12-14 weeks
Placebo Comparator: Group B
Randomized subjects receiving placebo comparator
Other: Placebo
2 tablets PO 3 times a day for 12-14 weeks

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, antiarrhytmics , 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 lapband 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131299

Contacts
Contact: Marcelo J Amar, M.D. (301) 402-0521 mamar@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Marcelo J Amar, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01131299     History of Changes
Other Study ID Numbers: 100088, 10-H-0088
Study First Received: May 25, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HDL
Cholesterol
Lipoproteins
Serum Lipids
Alpha-Cylodextrin
Atherosclerosis
Heart Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014