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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05313178
Other study ID # IRB-21-57
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date February 1, 2022

Study information

Verified date March 2022
Source Lindenwood University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bacillus Coagulans GBI-30, 6086
In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period.

Locations

Country Name City State
United States Lindenwood University Saint Charles Missouri

Sponsors (2)

Lead Sponsor Collaborator
Lindenwood University Increnovo, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Concentrations of Amino Acids in Blood Plasma Concentrations of Amino Acids in Blood 4 hours
Secondary Adverse Events Incidence and associations of reported adverse events 4 hours
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