Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-31 @ 12:36 AM
Study NCT ID:
NCT03002168
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Lipid Content in Stool After Alpha-cyclodextrin
Sponsor:
Mayo Clinic
Organization:
Study Overview
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
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMAT
Brief 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.
The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester, Minnesota.
Detailed 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: