ObesityFAT ABSORBERNCT01910558
The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
A study testing Alpha-cyclodextrin and digestible starch, Alpha-cyclodextrin and Digestible starch in people with Obesity and Cardiovascular Disease, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Disease
- What is being tested?
- Alpha-cyclodextrin and digestible starch, Alpha-cyclodextrin and Digestible starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 20 and 30 kg/m2 inclusive
- Weight ≥ 65 kg for females, and ≥ 55 kg for males
Who cannot join
- Pregnant or nursing.
- Diabetes Mellitus
- Any medication to reduce lipids
- History of gastrointestinal surgery, except for cholecystectomy or appendectomy
- History of malabsorption
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control
Read the detailed description
Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.
- Conditions
- Obesity, Cardiovascular Disease
- Being tested
- Alpha-cyclodextrin and digestible starch, Alpha-cyclodextrin, Digestible starch
- Keywords
- Alpha-cyclodextrin, Dietary fiber, Fecal fat, Saturated fat
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-cyclodextrin and digestible starchDietary supplement
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch
Alpha-cyclodextrinDietary supplement
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
Digestible starchDietary supplement
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch
| Study group | Role | What they receive |
|---|---|---|
| Alpha-cyclodextrin and digestible starch | Active comparator | Supplementation with three grams alpha cyclodextrin with three grams of digestible starch Receives: Dietary Supplement: Alpha-cyclodextrin |
| Alpha-cyclodextrin | Experimental | Supplementation with six grams of alpha-cyclodextrin Receives: Dietary Supplement: Alpha-cyclodextrin and digestible starch |
| Digestible Starch | Placebo comparator | Supplementation with six grams of digestible starch Receives: Dietary Supplement: Digestible starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Fat Excretion compared at three time periods.
Each subject will consume a different product every six consecutive days which is called a feeding period. On the fourth, fifth, and sixth day of each feeding period, a comparison of fat excretion will be measured through a stool sample. These feeding periods will occur for three consecutive six days totaling eighteen days of feeding. 6+6+6=18
Measured: Assessment of change at each fourth, fifth, and sixth day of each feeding period.
Secondary outcomes (1)
Adverse events
Subjects will be asked if they experienced any adverse events. All adverse events will be recorded and evaluated.
Measured: The duration of the 18 days in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Cancelled by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Nutrition LLC
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank L Greenway, M.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910558
- Sponsor's protocol ID
- PBRC 2013-043
- Acronym
- FAT ABSORBER
- Status last verified
- Apr 2016
- First submitted
- 22 Jul 2013
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.
PubMed 21127475Grunberger G, Jen KL, Artiss JD. The benefits of early intervention in obese diabetic patients with FBCx: a new dietary fibre. Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. doi: 10.1002/dmrr.687.
PubMed 17013969Artiss JD, Brogan K, Brucal M, Moghaddam M, Jen KL. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism. 2006 Feb;55(2):195-202. doi: 10.1016/j.metabol.2005.08.012.
PubMed 16423626
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion
- ClinicalTrials.gov ID
- NCT01910558
- Acronym / sponsor ID
- FAT ABSORBER / PBRC 2013-043
- Conditions
- Obesity, Cardiovascular Disease
- Keywords
- Alpha-cyclodextrin, Dietary fiber, Fecal fat, Saturated fat
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Quest Nutrition LLC
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control
Detailed description
Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha-cyclodextrin and digestible starch | Active comparator | Dietary Supplement: Alpha-cyclodextrinSupplementation with three grams alpha cyclodextrin with three grams of digestible starch |
| Alpha-cyclodextrin | Experimental | Dietary Supplement: Alpha-cyclodextrin and digestible starchSupplementation with six grams of alpha-cyclodextrin |
| Digestible Starch | Placebo comparator | Dietary Supplement: Digestible starchSupplementation with six grams of digestible starch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 20 and 30 kg/m2 inclusive
- Weight ≥ 65 kg for females, and ≥ 55 kg for males
Key exclusion criteria (5 listed)
- Pregnant or nursing.
- Diabetes Mellitus
- Any medication to reduce lipids
- History of gastrointestinal surgery, except for cholecystectomy or appendectomy
- History of malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-cyclodextrin and digestible starchWeight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch | Dietary supplement | Alpha-cyclodextrin |
| Alpha-cyclodextrinWeight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin | Dietary supplement | Alpha-cyclodextrin and digestible starch |
| Digestible starchWeight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch | Dietary supplement | Digestible Starch |
Primary outcome
Fecal Fat Excretion compared at three time periods.
Time frame: Assessment of change at each fourth, fifth, and sixth day of each feeding period.
Each subject will consume a different product every six consecutive days which is called a feeding period. On the fourth, fifth, and sixth day of each feeding period, a comparison of fat excretion will be measured through a stool sample. These feeding periods will occur for three consecutive six days totaling eighteen days of feeding. 6+6+6=18
1 secondary outcome
Adverse events
Time frame: The duration of the 18 days in the study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Background: PubMed 21127475Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.
- Background: PubMed 17013969Grunberger G, Jen KL, Artiss JD. The benefits of early intervention in obese diabetic patients with FBCx: a new dietary fibre. Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. doi: 10.1002/dmrr.687.
- Background: PubMed 16423626Artiss JD, Brogan K, Brucal M, Moghaddam M, Jen KL. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism. 2006 Feb;55(2):195-202. doi: 10.1016/j.metabol.2005.08.012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank L Greenway, M.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-cyclodextrin and digestible starch, Alpha-cyclodextrin and Digestible starch in people with Obesity and Cardiovascular Disease, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Fat Excretion compared at three time periods. (time frame: Assessment of change at each fourth, fifth, and sixth day of each feeding period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.