Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT04427020
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
Sponsor:
Lindenwood University
Organization:
Study Overview
Official Title:
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
Status:
COMPLETED
Status Verified Date:
2020-06
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:
None
Brief Summary:
The purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption after a two-week pattern of milk protein supplementation with and without the addition of Bacillus coagulans GBI-30, 6086.
Detailed Description:
The study will be conducted using a randomized, double-blind, crossover study design. 30 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a healthy history questionnaire to determine study eligibility. Two supplementation protocols that each span two weeks will be completed and separated with a washout period of three weeks. For each study visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10-hour fast. For two weeks prior to each study visit, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured using bioelectrical impedance analysis (BIA). Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will used to collect approximately 10mL of venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after ingestion of their final assigned supplementation dose for that period in the study protocol. Participants will be provided 200 mL of cold water to ingest after each blood collection. Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded according to Institutional Review Board-stipulated guidelines. Study participants will be provided an additional two-week supply of the alternative treatment to begin after observing a three-week washout. After two weeks of supplementation, study participants will return to the laboratory for their remaining testing visit. All subsequent study visits will be completed in a randomized fashion to minimize any order effects from testing.
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?: