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

NCT06701604 | Not Yet Recruiting

• 1 other identifier: PCTB202104D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Amino Acid Absorption; Probiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Comprehensive metabolic panel

  Day 0, Day 22, Day 65

• Blood CBC panel

  Day 0, Day 22, Day 65

Study Arms (2)

Milk Protein + Probiotic

EXPERIMENTAL

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

Milk Protein + Placebo

PLACEBO COMPARATOR

Arm receiving placebo matching investigational product + a 25-gram dose of milk protein concentrate given daily for 3 weeks

Dietary Supplement: Placebo + Milk Protein

Interventions

Single Strain Probiotic + Milk Protein DIETARY_SUPPLEMENT

• Both conditions matched flavor, color, and serving size

Milk Protein + Probiotic

Placebo + Milk Protein DIETARY_SUPPLEMENT

• Both conditions matched flavor, color, and serving size

Milk Protein + Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• University of Mary Hardin-Baylor: collaborator

Study Sites (1)

The University of Mary Hardin-Baylor

Belton, Texas, 76513, United States

Location

MeSH Terms

Interventions

Milk Proteins

Intervention Hierarchy (Ancestors)

Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Milk; Dairy Products; Food and Beverages

Central Study Contacts

Lem Taylor, PhD

CONTACT

254-295-4895; ltaylor@umhb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: December 2, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)