Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding

Not Applicable

Not yet recruiting

• Conditions: Amino Acid Absorption; Probiotic

• Registration Number: NCT06701604
• Lead Sponsor: The Archer-Daniels-Midland Company

Brief Summary

The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.

Detailed Description

The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-02
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Participants will be male or female between the ages of 18-35 years;
• Participants have not been consuming any nutritional supplements for the preceding 6-week period;
• Participants have not been consuming any ergogenic aids for the preceding 6-week period;
• Participant has provided written and dated informed consent to participate in the study;
• Participant is willing and able to comply with the protocol;
• Participant is apparently healthy and free from disease, as determined by a health history questionnaire;

Exclusion Criteria

• Participant is allergic to any ingredient in the nutritional supplement or placebo;
• Participant is not pregnant or trying to become pregnant, nor breast feeding;
• Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;
• Participant currently ingests nicotine or has quit within the last 6 months;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Rate of amino acid absorption	Day 0, Day 22, Day 65	To determine if the addition of a probiotic to milk protein ingestion changes the rate (in minutes) to which amino acids are absorbed into our bloodstream.
Concentration of amino acid absorption	Day 0, Day 22, Day 65	To determine if the addition of a probiotic to milk protein ingestion changes the extent (concentration in millimoles/Liter) to which amino acids are absorbed into our bloodstream.

Secondary Outcome Measures

Name	Time	Method
Comprehensive metabolic panel	Day 0, Day 22, Day 65	Comprehensive metabolic panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data.; • All measures are assessed by blood or serum assay analysis
Blood CBC panel	Day 0, Day 22, Day 65	Blood CBC panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data.; • All measures are assessed by blood or serum assay analysis

Trial Locations

Locations (1)

The University of Mary Hardin-Baylor; 🇺🇸 Belton, Texas, United States