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
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.
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.
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