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

NCT ID: NCT06701604

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2026-01-15

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.

Conditions

Amino Acid Absorption; Probiotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Single Strain Probiotic + Milk Protein

Intervention Type: DIETARY_SUPPLEMENT

• Both conditions matched flavor, color, and serving size

Milk Protein + Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo + Milk Protein

Intervention Type: DIETARY_SUPPLEMENT

• Both conditions matched flavor, color, and serving size

Interventions

Single Strain Probiotic + Milk Protein

• Both conditions matched flavor, color, and serving size

Intervention Type: DIETARY_SUPPLEMENT

Placebo + Milk Protein

• Both conditions matched flavor, color, and serving size

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Mary Hardin-Baylor

OTHER

Sponsor Role: collaborator

The Archer-Daniels-Midland Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Mary Hardin-Baylor

Belton, Texas, United States

Countries

United States

Central Contacts

Lem Taylor, PhD

Role: CONTACT

ltaylor@umhb.edu

254-295-4895

Facility Contacts

Lem Taylor, PhD

Role: primary

ltaylor@umhb.edu

254-295-4895

Other Identifiers

PCTB202104D

Identifier Type: -

Identifier Source: org_study_id