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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02999620




Registration number
NCT02999620
Ethics application status
Date submitted
19/12/2016
Date registered
21/12/2016
Date last updated
11/08/2017

Titles & IDs
Public title
FBCx (Alpha-CD) Mechanism of Action Trial
Scientific 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
Secondary ID [1] 0 0
SFIR-FMAT-US01
Universal Trial Number (UTN)
Trial acronym
FMAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Alpha-cyclodextrin
Other interventions - Placebo

Active Comparator: Alpha-cycoldextrin - All 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.

Placebo Comparator: Placebo - All 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.


Other interventions: Alpha-cyclodextrin
Alpha-cyclodextrin (a-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.

Other interventions: Placebo
Identical looking placebo tablet to active (Alpha-cyclodextrin)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
72 hours
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 hours

Eligibility
Key inclusion criteria
- 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

- 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
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- 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 a-CD components

- Any other health condition that would preclude participation in the study in the
judgment of the principal investigator

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Mayo Clinic - Rochester
Recruitment postcode(s) [1] 0 0
55905 - Rochester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SFI Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Mayo Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02999620
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael D Jensen, M.D.
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications