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Healthy VolunteersFMATNCT02999620

FBCx (Alpha-CD) Mechanism of Action Trial

A study testing Alpha-cyclodextrin in people with Healthy Volunteers, run by SFI Research at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as compared to placebo when consumed with a standardized radiolabeled fatty meal. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Alpha-cyclodextrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteAustralia
Study dates
Jan 2017to Jul 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 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 - ≤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/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3

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
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  • Evidence or history of substance or alcohol abuse
  • History of major depression (per DSM4 criteria), bipolar disorder, or schizophrenia
  • Current use of prescription or non-prescription weight loss products (≥ 2 week washout period is required to become eligible)
  • Smoking ≥ 30 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 components
  • 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.

Australia1 site

  • Mayo Clinic

    Rochester, New South Wales, 55905

Other trials in Australia

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

To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as compared to placebo when consumed with a standardized radiolabeled fatty meal.

Read the detailed description

This clinical investigation will determine the fat losses in stool associated with alpha-CD use as compared to placebo when ingested with a standardized liquid breakfast (100 microCi of [3H]triolein) and 20 microCi of [14C]tripalmitin). The ingested dose will be 2 g of α-CD at each of three meals per day for 2 days.

Eight subjects will be recruited in a two-way crossover design consisting of two treatment periods.

Treatment 1 requires all subjects to receive α-CD and a meal containing the fatty acid radiotracers Treatment 2 requires all subjects to receive placebo and a meal containing the fatty acid radiotracers All subjects will be observed for 48 hours as an in-patient, and a further 24 hours as an out-patient following the meal containing the radiotracer and will then undergo at least a further ≥ 14 day washout period before crossing over to the alternate treatment.

All subjects randomized to the α-CD treatment arm will receive 2 g of α-CD (2 x 1 g tablets), at each of three meals per day for 2 days. During the placebo phase, all subjects will receive two identical-looking placebo tablets.

Being tested
Alpha-cyclodextrin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alpha-cyclodextrinDietary supplement

    Also called Calorease, Nuvexa, Mirafit, FBCx, Alfadex

    Alpha-cyclodextrin (α-CD) is a soluble dietary fiber that has a history of use in foods and as a pharmaceutical excipient. Recently the ability of the fiber to bind to dietary fat has led to further investigation of the possible health benefits of dietary supplementation with this fiber.

  • PlaceboDietary supplement

    Identical looking placebo tablet to active (Alpha-cyclodextrin)

Study groups in NCT02999620
Study groupRoleWhat they receive
Alpha-cycoldextrinActive comparatorAll subjects randomized to receive Alpha-cycoldextrin will orally ingest two tablets containing Alpha-cyclodextrin, with their standardized liquid breakfast (100 micro Ci of [3H]triolein and 20 micro Ci of [14C]tripalmitin). The tablets will be consumed with 150 ml of still 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. During this time they will undergo a meal fatty acid metabolism study, through blood and fecal sampling, to assess meal fatty acid oxidation and storage.
Receives: Dietary Supplement: Alpha-cyclodextrin
PlaceboPlacebo comparatorAll subjects randomized to receive placebo will orally ingest two placebo tablets with their standardized liquid breakfast (100 micro Ci of [3H]triolein and 20 micro Ci of [14C]tripalmitin). The tablets will be consumed with 150 ml of still 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. During this time they will undergo a meal fatty acid metabolism study, through blood and fecal sampling, to assess meal fatty acid oxidation and storage.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiolabeled lipid content in stool

    The primary endpoint for this investigation is to measure the total excretion of radiolabeled fat in feces over 72 hours.

    Measured: 72 hours

Secondary outcomes (1)

  1. Blood glucose levels

    Blood Glucose will be measured hourly from fasting to 6 hours post radiotraced meal on the first day of each treatment period.

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJun 2017
  4. Study completionJul 2017

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999620
Sponsor's protocol ID
SFIR-FMAT-US01
Acronym
FMAT
Status last verified
Aug 2017
First submitted
19 Dec 2016
Last updated
11 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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 21127475

  • Jarosz PA, Fletcher E, Elserafy E, Artiss JD, Jen KL. The effect of alpha-cyclodextrin on postprandial lipid and glycemic responses to a fat-containing meal. Metabolism. 2013 Oct;62(10):1443-7. doi: 10.1016/j.metabol.2013.05.015. Epub 2013 Jun 24.

    PubMed 23806736

Questions about this trial

What is this clinical trial studying?

A study testing Alpha-cyclodextrin in people with Healthy Volunteers, run by SFI Research at 1 site in Australia.

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 11 Aug 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 Australia. 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?

Radiolabeled lipid content in stool (time frame: 72 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 NCT02999620, which also lists 2 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 11 Aug 2017.

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