Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/8/2015 |
| Start Date: | March 2010 |
| End Date: | December 2015 |
| Contact: | Marcelo J Amar, M.D. |
| Email: | mamar@mail.nih.gov |
| Phone: | (301) 402-0521 |
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.
- 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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-4000
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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