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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
8
Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.
Placebo tablets identical in appearance to the active comparator
A MicroCurie (µCi) is a measure of radioactivity.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in lipid content in stool, measured using 3^H radiolabeled tracer
Time frame: Baseline, 6 hours
Change in lipid content in stool, measured using 14^C radiolabeled tracer
Time frame: Baseline, 6 hours
Change in blood triglyceride concentrations, measured using 3^H radiolabeled tracer
Time frame: Baseline, 6 hours
Change in blood triglyceride concentrations, measured using 14^C radiolabeled tracer
Time frame: Baseline, 6 hours
Change in blood glucose concentration
Time frame: Baseline, 6 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A MicroCurie (µCi) is a measure of radioactivity.