Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate (ABC)

Lindenwood University

Status

Completed

Conditions

Protein Malabsorption

Treatments

Dietary Supplement: Bacillus Coagulans GBI-30, 6086

Study type

Interventional

Funder types

Other

Identifiers

NCT05313178

IRB-21-57

Details and patient eligibility

About

The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women.

Full description

Once determined eligible and providing consent, 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. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.

Enrollment

30 patients

Sex

Female

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All participants will be between the ages of 50-70 years
Completing at least 30 minutes of physical activity at minimum three days per week

Exclusion criteria

As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease
Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
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 overnight (8-10 hours)
Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit
Women who are pregnant
Women who are lactose intolerant