Clinical trial NCT06701604: Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
Official title: Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amino Acid Absorption
Probiotic
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: University of Mary Hardin-Baylor
First posted: 2024-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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;

Primary outcomes:
measure: Rate of amino acid absorption
timeFrame: Day 0, Day 22, Day 65
measure: Concentration of amino acid absorption
timeFrame: Day 0, Day 22, Day 65
Secondary outcomes:
measure: Comprehensive metabolic panel
timeFrame: Day 0, Day 22, Day 65
measure: Blood CBC panel
timeFrame: Day 0, Day 22, Day 65
Other outcomes:
Locations:
city: Belton
country: United States
facility: The University of Mary Hardin-Baylor
state: Texas
Study officials:
References: