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NCT Number: NCT06701604

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Single Strain Probiotic + Milk Protein

Dietary Supplement
  • Both conditions matched flavor, color, and serving size

Placebo + Milk Protein

Dietary Supplement
  • Both conditions matched flavor, color, and serving size

Primary outcomes

  1. Rate of amino acid absorption

    Time frame: 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.

  2. Concentration of amino acid absorption

    Time frame: 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 outcomes

  1. Comprehensive metabolic panel

    Time frame: 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
  2. Blood CBC panel

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lem Taylor, PhD

CONTACT

[email protected]

254-295-4895

Sponsors and collaborators

Lead sponsor

The Archer-Daniels-Midland Company

Industry

Collaborators

  • University of Mary Hardin-Baylor

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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