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

Not Applicable

Completed

• Conditions: Protein Malabsorption
• Interventions: Dietary Supplement: Bacillus Coagulans GBI-30, 6086

• Registration Number: NCT05313178
• Lead Sponsor: Lindenwood University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Milk Protein	Bacillus Coagulans GBI-30, 6086	25-gram dose of milk protein concentrate
Milk Protein and Probiotic	Bacillus Coagulans GBI-30, 6086	25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086

Primary Outcome Measures

Name	Time	Method
Plasma Concentrations of Amino Acids in Blood	4 hours	Plasma Concentrations of Amino Acids in Blood

Secondary Outcome Measures

Name	Time	Method
Adverse Events	4 hours	Incidence and associations of reported adverse events

Trial Locations

Locations (1)

Lindenwood University; 🇺🇸 Saint Charles, Missouri, United States