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

Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Amino Acid Absorption; Probiotic
• Intervention / Treatment: Dietary supplement: Single Strain Probiotic + Milk Protein; Dietary supplement: Placebo + Milk Protein

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lem Taylor, PhD; Phone Number: 254-295-4895; Email: ltaylor@umhb.edu

Study Locations

• United States
  • Texas
    • Belton, Texas, United States, 76513
      • The University of Mary Hardin-Baylor
      • Contact: Lem Taylor, PhD; Phone Number: 254-295-4895; Email: ltaylor@umhb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milk Protein + Probiotic; Arm receiving investigational product (probiotic) in the form of a capsule with a dose of 1B Colony Forming Unit (CFU) per day + a 25-gram dose of milk protein concentrate given daily for 3 weeks	Dietary supplement: Single Strain Probiotic + Milk Protein; • Both conditions matched flavor, color, and serving size
Placebo Comparator: Milk Protein + Placebo; Arm receiving placebo matching investigational product + a 25-gram dose of milk protein concentrate given daily for 3 weeks	Dietary supplement: Placebo + Milk Protein; • Both conditions matched flavor, color, and serving size

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of amino acid absorption	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.	Day 0, Day 22, Day 65
Concentration of amino acid absorption	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.	Day 0, Day 22, Day 65

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive metabolic panel	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	Day 0, Day 22, Day 65
Blood CBC panel	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	Day 0, Day 22, Day 65

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: University of Mary Hardin-Baylor

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: PCTB202104D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No