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

Protein Malabsorption Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313178
• Other study ID #: IRB-21-57
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Malabsorption Syndromes
• Protein Malabsorption

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