NCT02999620

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

December 19, 2016

Last Update Submit

August 9, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (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.

    72 hours

Secondary Outcomes (1)

  • Blood glucose levels

    6 hours

Other Outcomes (1)

  • Blood Trigliceride Levels

    6 hours

Study Arms (2)

Alpha-cycoldextrin

ACTIVE COMPARATOR

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.

Dietary Supplement: Alpha-cyclodextrin

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Alpha-cyclodextrinDIETARY_SUPPLEMENT

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.

Also known as: Calorease, Nuvexa, Mirafit, FBCx, Alfadex
Alpha-cycoldextrin
PlaceboDIETARY_SUPPLEMENT

Identical looking placebo tablet to active (Alpha-cyclodextrin)

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, New South Wales, 55905, Australia

Location

Related Publications (2)

  • 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.

    PMID: 21127475RESULT

  • 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.

    PMID: 23806736RESULT

MeSH Terms

Interventions

alpha-cyclodextrin

Study Officials

  • Michael D Jensen, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 21, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)