Clinical trial NCT05313178: Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate
Official title: Acute Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate in Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Malabsorption
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: Increnovo, LLC
First posted: 2022-04-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, crossover study design
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Concentrations of Amino Acids in Blood
timeFrame: 4 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: 4 hours
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Lindenwood University
state: Missouri
Study officials:
References: