30 Participants Needed

Probiotics for Amino Acid Absorption

LT
Overseen ByLem Taylor, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: The Archer-Daniels-Midland Company

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 the probiotic treatment generally safe for humans?

Probiotics, including strains like Lactobacillus acidophilus and Bifidobacterium, have been studied for safety and are generally considered safe for human use, as seen in trials for conditions like antibiotic-associated diarrhea.12345

How does the Single Strain Probiotic treatment improve amino acid absorption compared to other treatments?

The Single Strain Probiotic treatment is unique because it enhances the absorption of amino acids from plant proteins, which are typically less efficiently absorbed than animal proteins. This probiotic works by positively altering the gut microbiota, making it easier for the body to absorb essential amino acids from plant-based sources.678910

What data supports the effectiveness of the treatment Single Strain Probiotic for amino acid absorption?

Research suggests that probiotics, like Bacillus subtilis DE111, can influence the body's response to protein intake, potentially improving amino acid absorption. Additionally, interactions between dietary amino acids and gut bacteria can enhance nutrient absorption and overall health.17111213

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
See 2 more

Exclusion Criteria

Participant is allergic to any ingredient in the nutritional supplement or placebo
Participant currently ingests nicotine or has quit within the last 6 months
Participant is not pregnant or trying to become pregnant, nor breastfeeding
See 1 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Milk Protein + ProbioticExperimental Treatment1 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 + PlaceboPlacebo Group1 Intervention
Arm receiving placebo matching investigational product + a 25-gram dose of milk protein concentrate given daily for 3 weeks

Find a Clinic Near You

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.
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

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. [2022]
Plasma Amino Acid Response to Whey Protein Ingestion Following 28 Days of Probiotic (Bacillus subtilis DE111) Supplementation in Active Men and Women. [2021]
A meta-analysis on the efficacy of probiotics for maintenance of remission and prevention of clinical and endoscopic relapse in Crohn's disease. [2022]
Selective nourishing of gut microbiota with amino acids: A novel prebiotic approach? [2023]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Gastrointestinal Interaction between Dietary Amino Acids and Gut Microbiota: With Special Emphasis on Host Nutrition. [2021]
Probiotic lactobacilli: an innovative tool to correct the malabsorption syndrome of vegetarians? [2018]
Randomised placebo-controlled double blind multicentric trial on efficacy and safety of Lactobacillus acidophilus LA-5 and Bifidobacterium BB-12 for prevention of antibiotic-associated diarrhoea. [2022]
Enhancing Bioaccessibility of Plant Protein Using Probiotics: An In Vitro Study. [2023]
The role of Lactobacillus reuteri DSM 17938 for the absorption of iron preparations in children with iron deficiency anemia. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Probiotic Administration Increases Amino Acid Absorption from Plant Protein: a Placebo-Controlled, Randomized, Double-Blind, Multicenter, Crossover Study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Absorptive transport of amino acids by the rat colon. [2021]
Escherichia coli, an Intestinal Microorganism, as a Biosensor for Quantification of Amino Acid Bioavailability. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Contribution of microbial amino acids to amino acid homeostasis of the host. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security