Determining Lipid Content in Stool After Alpha-cyclodextrin — FMAT  

Healthy Participants Clinical Trial

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

Status Completed

Clinical 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.

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy Participants

• NCT number: NCT03002168
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: N/A
• Start date: January 20, 2017
• Completion date: June 5, 2017