Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single Strain Probiotic + Milk Protein, Placebo + Milk Protein.
- Who it may be relevant to
- Registry conditions: Amino Acid Absorption, Probiotic. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation
Overview
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.
Interventions
- Dietary supplement Single Strain Probiotic + Milk Protein
• Both conditions matched flavor, color, and serving size - Dietary supplement Placebo + Milk Protein
• Both conditions matched flavor, color, and serving size
Primary outcome measures
- Rate of amino acid absorption [Time frame: Day 0, Day 22, Day 65]
- Concentration of amino acid absorption [Time frame: Day 0, Day 22, Day 65]
Secondary outcome measures (2)
- Comprehensive metabolic panel [Time frame: Day 0, Day 22, Day 65]
- Blood CBC panel [Time frame: Day 0, Day 22, Day 65]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- The University of Mary Hardin-Baylor — Belton
Identifiers
NCT: NCT06701604 · PCTB202104D