Determining Lipid Content in Stool After Alpha-cyclodextrin

NCT03002168 | Completed

• 1 other identifier: 16-005006
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester, Minnesota.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Change in lipid content in stool, measured using 3^H radiolabeled tracer

  Baseline, 6 hours

Secondary Outcomes (4)

• Change in lipid content in stool, measured using 14^C radiolabeled tracer

  Baseline, 6 hours

• Change in blood triglyceride concentrations, measured using 3^H radiolabeled tracer

  Baseline, 6 hours

• Change in blood triglyceride concentrations, measured using 14^C radiolabeled tracer

  Baseline, 6 hours

• Change in blood glucose concentration

  Baseline, 6 hours

Study Arms (2)

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.

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.

Dietary Supplement: Placebo; Radiation: Triolein radiolabeled with 100 microcuries of 3^Hydrogen; Radiation: Tripalmitin radiolabeled with 20 microcuries of 14^Carbon

Interventions

Tripalmitin radiolabeled with 20 microcuries of 14^Carbon RADIATION

A MicroCurie (µCi) is a measure of radioactivity.

Alpha-cyclodextrin; Placebo

Alpha-cyclodextrin DIETARY_SUPPLEMENT

Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.

Also known as: FBCx, Calorease

Alpha-cyclodextrin

Placebo DIETARY_SUPPLEMENT

Placebo tablets identical in appearance to the active comparator

Placebo

Triolein radiolabeled with 100 microcuries of 3^Hydrogen RADIATION

A MicroCurie (µCi) is a measure of radioactivity.

Alpha-cyclodextrin; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

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, 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

Sponsors & Collaborators

• Mayo Clinic: lead
• SFI Research: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 30107536 DERIVED

MeSH Terms

Interventions

alpha-cyclodextrin

Study Officials

• Michael D Jensen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: January 20, 2017
• Primary Completion: June 5, 2017
• Study Completion: June 5, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)