Cardiovascular Disease Clinical Trial
Official title:
Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
- 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. Epub 2004 Mar 8. Erratum in: N Engl J Med. 2006 Feb 16;354(7):778. — View Citation
Fedder DO, Koro CE, L'Italien GJ. New National Cholesterol Education Program III guidelines for primary prevention lipid-lowering drug therapy: projected impact on the size, sex, and age distribution of the treatment-eligible population. Circulation. 2002 Jan 15;105(2):152-6. — View Citation
Shepherd J. Dyslipidaemia in diabetic patients: time for a rethink. Diabetes Obes Metab. 2007 Sep;9(5):609-16. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Serum Cholesterol Levels for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline | Total cholesterol levels were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm. | 24-28 weeks | No |
Secondary | Small LDL Particle Number (by NMR Spectrometry of Lipoproteins) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline | Small LDL particle numbers were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm. | 24-28 weeks | No |
Secondary | Serum Glucose Levels After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline | Serum glucose levels was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm. | 24-28 weeks | No |
Secondary | Lipoprotein Insulin Resistance Index (LIRI) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline | LIRI was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm. | 24-28 weeks | No |
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