FBCx (Alpha-CD) Mechanism of Action Trial — FMAT  

Healthy Volunteers 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

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.

Clinical Trial Description

This clinical investigation will determine the fat losses in stool associated with alpha-CD use as compared to placebo when ingested with a standardized liquid breakfast (100 microCi of [3H]triolein) and 20 microCi of [14C]tripalmitin). The ingested dose will be 2 g of α-CD at each of three meals per day for 2 days.

Eight subjects will be recruited in a two-way crossover design consisting of two treatment periods.

Treatment 1 requires all subjects to receive α-CD and a meal containing the fatty acid radiotracers Treatment 2 requires all subjects to receive placebo and a meal containing the fatty acid radiotracers All subjects will be observed for 48 hours as an in-patient, and a further 24 hours as an out-patient following the meal containing the radiotracer and will then undergo at least a further ≥ 14 day washout period before crossing over to the alternate treatment.

All subjects randomized to the α-CD treatment arm will receive 2 g of α-CD (2 x 1 g tablets), at each of three meals per day for 2 days. During the placebo phase, all subjects will receive two identical-looking placebo tablets. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT02999620
• Study type: Interventional
• Source: SFI Research
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Completion date: July 2017