Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
2 other identifiers
interventional
103
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
October 21, 2016
CompletedOctober 21, 2016
October 1, 2016
4.9 years
May 25, 2010
April 18, 2016
October 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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
24-28 weeks
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
24-28 weeks
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
24-28 weeks
Study Arms (2)
Alpha cyclodextrin first then placebo
ACTIVE COMPARATORRandomized subjects will receive alpha cyclodextrin 2g orally three times a day for 12-14 weeks. After the one week washout, the subjects will receive 2 tablets orally of placebo (three times a day for 12-14 weeks).
Placebo first then Alpha cyclodextrin
PLACEBO COMPARATORParticipants will receive 2 tablets orally of placebo (three times a day for 12-14 weeks). The subjects will have a one-week washout. After the washout, the participants will receive alpha cyclodextrin 2g orally three times a day for 12-14 weeks.
Interventions
2 tablets PO 3 times a day for 12-14 weeks
2g PO 3 times a day for 12-14 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (4)
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. doi: 10.1161/hc0202.101971.
PMID: 11790693BACKGROUNDCannon 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. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
PMID: 15007110BACKGROUNDShepherd J. Dyslipidaemia in diabetic patients: time for a rethink. Diabetes Obes Metab. 2007 Sep;9(5):609-16. doi: 10.1111/j.1463-1326.2006.00642.x.
PMID: 17697054BACKGROUNDAmar MJ, Kaler M, Courville AB, Shamburek R, Sampson M, Remaley AT. Randomized double blind clinical trial on the effect of oral alpha-cyclodextrin on serum lipids. Lipids Health Dis. 2016 Jul 12;15(1):115. doi: 10.1186/s12944-016-0284-6.
PMID: 27405337DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marcelo Amar
- Organization
- NIH NHLBI
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo J Amar, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Officer (Research)
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 26, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
October 21, 2016
Results First Posted
October 21, 2016
Record last verified: 2016-10