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

Lindenwood University

Status

Completed

Conditions

Amino Acid Absorption

Treatments

Dietary Supplement: Milk protein

Dietary Supplement: Milk protein + GBI-30

Study type

Interventional

Funder types

Other

Identifiers

NCT04427020

IRB-20-15

Details and patient eligibility

About

The purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption after a two-week pattern of milk protein supplementation with and without the addition of Bacillus coagulans GBI-30, 6086.

Full description

The study will be conducted using a randomized, double-blind, crossover study design. 30 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a healthy history questionnaire to determine study eligibility. Two supplementation protocols that each span two weeks will be completed and separated with a washout period of three weeks. For each study visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10-hour fast. For two weeks prior to each study visit, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured using bioelectrical impedance analysis (BIA). Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will used to collect approximately 10mL of venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after ingestion of their final assigned supplementation dose for that period in the study protocol. Participants will be provided 200 mL of cold water to ingest after each blood collection. Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded according to Institutional Review Board-stipulated guidelines. Study participants will be provided an additional two-week supply of the alternative treatment to begin after observing a three-week washout. After two weeks of supplementation, study participants will return to the laboratory for their remaining testing visit. All subsequent study visits will be completed in a randomized fashion to minimize any order effects from testing.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All participants will be between the ages of 18-55 years.
Participants will be healthy and free of disease as determined by evaluation of a medical history.
Completing at least 30 minutes of moderate exercise three days per week

Exclusion criteria

Those individuals less than 18 and greater than 55 years of age will be excluded.
Any individual who is currently being treated for or diagnosed with a cardiac disorder or disease
Any individual who is currently being treated for or diagnosed with a respiratory disorder or disease
Any individual who is currently being treated for or diagnosed with a circulatory disorder or disease
Any individual who is currently being treated for or diagnosed with a musculoskeletal disorder or disease
Any individual who is currently being treated for or diagnosed with a metabolic disorder or disease
Any individual who is currently being treated for or diagnosed with obesity (defined as body mass index > 30 kg/m and body fat greater than 30%)
Any individual who is currently being treated for or diagnosed with an immune or autoimmune disorder or disease
Any individual who is currently being treated for or diagnosed with a psychiatric disorder or disease
Any individual who is currently being treated for or diagnosed with a hematological disorder or disease
Any individual who is currently being treated for or diagnosed with a neurological disorder or disease
Any individual who is currently being treated for or diagnosed with an endocrinological disorder or disease
Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for 12 hours prior to each visit will be excluded
Participants who do not or are not willing to abstain from exercise for 12 hours prior to each visit will be excluded.