Probiotics for Amino Acid Absorption

Overseen By Lem Taylor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Archer-Daniels-Midland Company

Disqualifiers: Allergies, Pregnancy, Nicotine use, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well the body absorbs amino acids (the building blocks of protein) when consuming milk protein with and without a specific probiotic. Participants will receive either a daily probiotic capsule (single strain probiotic) with milk protein or a placebo (a harmless pill resembling the real thing) with milk protein for three weeks. The trial seeks healthy adults who have not used any nutritional supplements or performance-enhancing products (such as energy boosters) in the past six weeks. As an unphased trial, it offers participants the chance to contribute to scientific understanding of nutrition and probiotics.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have been taking any nutritional supplements or performance-enhancing substances for the past 6 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers examined the safety of Lacticaseibacillus rhamnosus, the probiotic strain used in this trial, and found it generally safe for people. This strain commonly appears in foods and supplements and is well-tolerated by most individuals.

Another study on probiotics highlighted that safety depends on usage, including dosage and duration. In this trial, the probiotic is administered at a dose of 1 billion CFU (colony forming units) per day for three weeks, a typical amount for these supplements.

Overall, probiotics like Lacticaseibacillus rhamnosus are considered safe, with few reports of side effects when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for amino acid absorption issues primarily focus on dietary adjustments or enzyme supplements. However, the investigational probiotic treatment is unique because it introduces a single strain probiotic designed to enhance amino acid absorption naturally. This probiotic is administered in a capsule form and delivers a consistent daily dose of 1 billion Colony Forming Units (CFU), which is a novel approach compared to traditional methods. Researchers are excited because this could offer a natural, gut-friendly solution, potentially improving nutrient uptake more efficiently than current options. Plus, combining probiotics with milk protein might provide an added benefit, fostering better overall digestive health.

What evidence suggests that this probiotic is effective for amino acid absorption?

This trial will evaluate the effect of a single strain probiotic on amino acid absorption. Research has shown that probiotics can enhance the body's ability to absorb amino acids. In one study, probiotics increased the absorption of certain amino acids, such as methionine by 16.3% and histidine by 49.2%. This suggests that probiotics might help the body obtain more nutrients. Another study found that the probiotic strain B. longum effectively raised amino acid levels in the blood by altering gut bacteria. These findings suggest that adding probiotics to the diet could improve the body's use of amino acids from food. Participants in this trial will receive either a combination of milk protein and the investigational probiotic or milk protein and a placebo to assess these effects. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals interested in how their body absorbs amino acids from milk protein. Participants should be healthy and not currently taking any probiotics or medications that affect digestion.

Inclusion Criteria

Participant is willing and able to comply with the protocol

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

Exclusion Criteria

Participant is allergic to any ingredient in the nutritional supplement or placebo

Participant is not pregnant or trying to become pregnant, nor breastfeeding

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily 25-gram dose of milk protein with or without a probiotic for 3 weeks

3 weeks

Multiple visits for blood sampling

Washout

Participants undergo a washout period between treatment protocols

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Single Strain Probiotic

Trial Overview The study is testing if adding a single strain probiotic to milk protein changes the way amino acids are absorbed over three weeks, compared to just milk protein alone.

How Is the Trial Designed?

Group I: Milk Protein + Probiotic Experimental Treatment 1 Intervention

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 II: Milk Protein + Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

The Archer-Daniels-Midland Company

Lead Sponsor

Trials

17

Recruited

1,400+

University of Mary Hardin-Baylor

Collaborator

Trials

11

Recruited

230+

Published Research Related to This Trial

In a 52-week double-blind placebo-controlled study involving 32 patients with left-sided ulcerative colitis, the probiotic treatment Probio-Tec AB-25 did not show a significant advantage over placebo in maintaining clinical remission, with only 25% of the treatment group remaining in remission compared to 8% in the placebo group.

The median time to relapse was similar between the two groups, indicating that while Probio-Tec AB-25 was well tolerated, it did not provide a meaningful clinical benefit in preventing relapses of ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. Wildt, S., Nordgaard, I., Hansen, U., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7641926/

Probiotic Administration Increases Amino Acid Absorption ... Probiotic administration significantly increased methionine (+ 16.3%), histidine (+ 49.2%), valine (+ 24.7%), leucine (+ 25.2%), isoleucine (+ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06701604

Changes in Amino Acid Absorption After Adding a Probiotic ... The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein ...

3. nature.com nature.com/articles/s41598-025-15355-4

Strain specific effects of probiotic supplementation on ... B. longum demonstrated greater efficacy in increasing serum BCAAs and AAAs, possibly due to its stronger effects on gut microbiota modulation ...

4. link.springer.com link.springer.com/article/10.1007/s12602-022-10028-4

Probiotic BC30 Improves Amino Acid Absorption from Plant ... Established benefits from probiotic use include improvements in digestive and immune health [2]. Beyond these outcomes, probiotics can modulate ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1307734/full

Study of amino acids absorption and gut microbiome on ... Consumption of the supplement for 15 consecutive days demonstrated the likelihood of augmenting the absorption of total amino acids (AUC) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3023597/

Safety assessment of probiotics for human use - PMC The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0308814624038950

The revelation of high-yield amino acids and probiotic ... Therefore, this study aims to screen Lacticaseibacillus rhamnosus strains with potential probiotic properties and evaluate their safety, ...

8. link.springer.com link.springer.com/article/10.1007/s12602-025-10480-y

Postbiotic Supplementation Increases Amino Acid ... Supplementation of probiotic strains can enhance the absorption of amino acids from protein in the gut. The purpose of this study was to ...