Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02999620
Brief 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.
Detailed 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.
Study:
NCT02999620
Study Brief:
Protocol Section:
NCT02999620