Healthy ParticipantsFMATNCT03002168
Determining Lipid Content in Stool After Alpha-cyclodextrin
A study testing Alpha-cyclodextrin, Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon in people with Healthy Participants, run by Mayo Clinic at 1 site in United States.
Trial summary
The Investigator hypothesizes that the currently used dose of dietary ingredient alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared with placebo. The proposed studies will address the degree to which α-CD increases dietary fat loss. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Alpha-cyclodextrin, Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 5 Jun 2017
- 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
- Healthy weight stable individuals (defined as a Body Mass Index (BMI) of ≥18.5 and <27, and stable for at least the preceding two months from Screening).
- Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm or ova, for the duration of the study
- Subjects ≥18 and ≤60 years of age at screening
- Consistent regular bowel movement (defined as between 3 times a day, to 1 time per day)
- Provide Informed Consent
- Willing and able to complete study procedures within the study timelines
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- Adequate renal function: serum creatinine less than 1.5 x Upper Limit of Normal (ULN)
- Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN, unless Gilbert's syndrome has previously been confirmed for the subject
- Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm^3, absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 9 gram/deciLiter, and platelets ≥ 100,000/mm^3
Who cannot join
- Evidence of chronic pancreatitis
- Evidence of irritable bowel syndrome (medical or self-diagnosed)
- Previous gallbladder surgery
- Use of enemas and/or suppositories within 30 days of Screening
- Consuming ≥ 375 mg of caffeine per day (equivalent to 5 serves of 1 oz. restaurant style espresso per day)
- History of febrile illness within 5 days prior to Screening
Show all 18Show fewer
- Evidence or history of substance or alcohol abuse
- History of major depression, bipolar disorder, or schizophrenia (per DSM4 criteria; Diagnostic and Statistical Manual of Mental Disorders)
- Current use of prescription or non-prescription weight loss products (≥ 2 week washout period is required to become eligible)
- Smoking ≥ 20 cigarettes (~one pack) per week
- Significant dietary restrictions (incl. vegan, vegetarian diets and any subject not prepared to consume any of the standardized food/s)
- Evidence of an active eating disorder (incl. anorexia nervosa, bulimia, and/or obsessive compulsive disorders)
- Use of other investigational agent(s at the time of enrollment, or within 30 days or five half-lives of enrollment, whichever is longer
- Pregnant or lactating
- Current use of any medication known to affect gut motility
- History of malignancy, treated or untreated, within the past five years, with the exception of non-melanoma skin cancer and cervical carcinoma in situ
- A known history of hypersensitivity to any of the α-CD ingredients
- Any other health condition that would preclude participation in the study in the judgment of the principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Single Center, Randomized, Double-blind, Placebo Controlled, Two-way Crossover Study to Determine the Fat Losses in Stool Associated With Alpha-CD Use as Compared to Placebo Using a Radiotracer
The Investigator hypothesizes that the currently used dose of dietary ingredient alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared with placebo. The proposed studies will address the degree to which α-CD increases dietary fat loss.
The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester, Minnesota.
Read the detailed description
This is a single-center, randomized, double-blind, placebo controlled, two-way crossover trial in healthy volunteers. The primary objective is to determine the fat losses in stool associated with alpha-cyclodextrin use as compared to placebo using a radiotracer. The study design will include two treatment periods, assigned in random order:
- Treatment 1 consists of subjects receiving α-CD and a meal containing the fatty acid radiotracers
- Treatment 2 consists of subjects receiving placebo and a meal containing the fatty acid radiotracers
All subjects randomized to receive α-CD will orally ingest two tablets containing α-CD, or placebo, with a standardized liquid breakfast (100 µ Ci of [3H]triolein and 20 µ Ci of [14C] tripalmitin). The tablets will be consumed with 150 ml of still (uncarbonated) water immediately prior to consuming each meal.
Subjects will be observed for a period of 48 hours as an in-patient, and then an additional 24 hours as an out-patient following the breakfast meal containing the radiotracers. During this time the participants will undergo a meal fatty acid metabolism study, through hourly blood and fecal sampling, to assess meal fatty acid oxidation and storage.
The participants will then undergo a further ≥ 14 day washout period before crossing over to the alternate treatment, where all evaluations will be repeated.
- Conditions
- Healthy Participants
- Being tested
- Alpha-cyclodextrin, Placebo, Triolein radiolabeled with 100 microcuries of 3^Hydrogen, Tripalmitin radiolabeled with 20 microcuries of 14^Carbon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-cyclodextrinDietary supplement
Also called FBCx, Calorease
Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.
PlaceboDietary supplement
Placebo tablets identical in appearance to the active comparator
Triolein radiolabeled with 100 microcuries of 3^HydrogenRadiation
A MicroCurie (µCi) is a measure of radioactivity.
Tripalmitin radiolabeled with 20 microcuries of 14^CarbonRadiation
A MicroCurie (µCi) is a measure of radioactivity.
| Study group | Role | What they receive |
|---|---|---|
| Alpha-cyclodextrin | Active comparator | Two 1 gram Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets (6 grams) per day for the first two consecutive days of active treatment period. Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal. Receives: Dietary Supplement: Alpha-cyclodextrin; Radiation: Triolein radiolabeled with 100 microcuries of 3^Hydrogen; Radiation: Tripalmitin radiolabeled with 20 microcuries of 14^Carbon |
| Placebo | Placebo comparator | Two Placebo Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets per day for the first two consecutive days of placebo treatment period.Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal. Receives: Dietary Supplement: Placebo; Radiation: Triolein radiolabeled with 100 microcuries of 3^Hydrogen; Radiation: Tripalmitin radiolabeled with 20 microcuries of 14^Carbon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipid content in stool, measured using 3^H radiolabeled tracer
Measured: Baseline, 6 hours
Secondary outcomes (4)
Change in lipid content in stool, measured using 14^C radiolabeled tracer
Measured: Baseline, 6 hours
Change in blood triglyceride concentrations, measured using 3^H radiolabeled tracer
Measured: Baseline, 6 hours
Change in blood triglyceride concentrations, measured using 14^C radiolabeled tracer
Measured: Baseline, 6 hours
Change in blood glucose concentration
Measured: Baseline, 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start20 Jan 2017
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- SFI Research
- Responsible party
- Principal investigator, Michael D. Jensen, Mayo Clinic
- Investigators
- Michael D Jensen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002168
- Sponsor's protocol ID
- 16-005006
- Acronym
- FMAT
- Status last verified
- Nov 2017
- First submitted
- 21 Dec 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lytle KA, Harteneck DA, Noble AM, Jensen MD. The Soluble Fiber alpha-Cyclodextrin Does Not Increase the Fecal Losses of Dietary Fat in Adults-A Double-Blind, Randomized, Placebo-Controlled, Crossover Trial. J Nutr. 2018 Sep 1;148(9):1421-1425. doi: 10.1093/jn/nxy135.
PubMed 30107536
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Placebo Controlled, Two-way Crossover Study to Determine the Fat Losses in Stool Associated With Alpha-CD Use as Compared to Placebo Using a Radiotracer
- ClinicalTrials.gov ID
- NCT03002168
- Acronym / sponsor ID
- FMAT / 16-005006
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- SFI Research
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 23 Dec 2016 (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.
The Investigator hypothesizes that the currently used dose of dietary ingredient alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared with placebo. The proposed studies will address the degree to which α-CD increases dietary fat loss.
The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester, Minnesota.
Detailed description
This is a single-center, randomized, double-blind, placebo controlled, two-way crossover trial in healthy volunteers. The primary objective is to determine the fat losses in stool associated with alpha-cyclodextrin use as compared to placebo using a radiotracer. The study design will include two treatment periods, assigned in random order:
- Treatment 1 consists of subjects receiving α-CD and a meal containing the fatty acid radiotracers
- Treatment 2 consists of subjects receiving placebo and a meal containing the fatty acid radiotracers
All subjects randomized to receive α-CD will orally ingest two tablets containing α-CD, or placebo, with a standardized liquid breakfast (100 µ Ci of [3H]triolein and 20 µ Ci of [14C] tripalmitin). The tablets will be consumed with 150 ml of still (uncarbonated) water immediately prior to consuming each meal.
Subjects will be observed for a period of 48 hours as an in-patient, and then an additional 24 hours as an out-patient following the breakfast meal containing the radiotracers. During this time the participants will undergo a meal fatty acid metabolism study, through hourly blood and fecal sampling, to assess meal fatty acid oxidation and storage.
The participants will then undergo a further ≥ 14 day washout period before crossing over to the alternate treatment, where all evaluations will be repeated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-cyclodextrin | Active comparator | Dietary Supplement: Alpha-cyclodextrin, Radiation: Triolein radiolabeled with 100 microcuries of 3^Hydrogen, Radiation: Tripalmitin radiolabeled with 20 microcuries of 14^CarbonTwo 1 gram Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets (6 grams) per day for the first two consecutive days of active treatment period. Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Radiation: Triolein radiolabeled with 100 microcuries of 3^Hydrogen, Radiation: Tripalmitin radiolabeled with 20 microcuries of 14^CarbonTwo Placebo Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets per day for the first two consecutive days of placebo treatment period.Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy weight stable individuals (defined as a Body Mass Index (BMI) of ≥18.5 and <27, and stable for at least the preceding two months from Screening).
- Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm or ova, for the duration of the study
- Subjects ≥18 and ≤60 years of age at screening
- Consistent regular bowel movement (defined as between 3 times a day, to 1 time per day)
- Provide Informed Consent
Key exclusion criteria (18 listed)
- Evidence of chronic pancreatitis
- Evidence of irritable bowel syndrome (medical or self-diagnosed)
- Previous gallbladder surgery
- Use of enemas and/or suppositories within 30 days of Screening
- Consuming ≥ 375 mg of caffeine per day (equivalent to 5 serves of 1 oz. restaurant style espresso per day)
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-cyclodextrinAlso: FBCx, CaloreaseAlpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient. | Dietary supplement | Alpha-cyclodextrin |
| PlaceboPlacebo tablets identical in appearance to the active comparator | Dietary supplement | Placebo |
| Triolein radiolabeled with 100 microcuries of 3^HydrogenA MicroCurie (µCi) is a measure of radioactivity. | Radiation | Alpha-cyclodextrin, Placebo |
| Tripalmitin radiolabeled with 20 microcuries of 14^CarbonA MicroCurie (µCi) is a measure of radioactivity. | Radiation | Alpha-cyclodextrin, Placebo |
Primary outcome
Change in lipid content in stool, measured using 3^H radiolabeled tracer
Time frame: Baseline, 6 hours
4 secondary outcomes
Change in lipid content in stool, measured using 14^C radiolabeled tracer
Time frame: Baseline, 6 hours
Change in blood triglyceride concentrations, measured using 3^H radiolabeled tracer
Time frame: Baseline, 6 hours
Change in blood triglyceride concentrations, measured using 14^C radiolabeled tracer
Time frame: Baseline, 6 hours
Change in blood glucose concentration
Time frame: Baseline, 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 30107536Lytle KA, Harteneck DA, Noble AM, Jensen MD. The Soluble Fiber alpha-Cyclodextrin Does Not Increase the Fecal Losses of Dietary Fat in Adults-A Double-Blind, Randomized, Placebo-Controlled, Crossover Trial. J Nutr. 2018 Sep 1;148(9):1421-1425. doi: 10.1093/jn/nxy135.
- Individual participant dataSharing planned: Yes
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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.
Michael D Jensen, MD principal investigator
Mayo Clinic
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, Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon in people with Healthy Participants, run by Mayo Clinic 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 17 Nov 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in lipid content in stool, measured using 3^H radiolabeled tracer (time frame: Baseline, 6 hours). 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 NCT03002168, which also lists 1 linked publication.
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 17 Nov 2017; AzTrials last refreshed its copy on 4 Nov 2026.