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

NCT05313178 | Completed

• 1 other identifier: IRB-21-57
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein Malabsorption

Outcome Measures

Primary Outcomes (1)

• Plasma Concentrations of Amino Acids in Blood

  Plasma Concentrations of Amino Acids in Blood

  4 hours

Secondary Outcomes (1)

• Adverse Events

  4 hours

Study Arms (2)

Milk Protein

PLACEBO COMPARATOR

25-gram dose of milk protein concentrate

Dietary Supplement: Bacillus Coagulans GBI-30, 6086

Milk Protein and Probiotic

EXPERIMENTAL

25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086

Dietary Supplement: Bacillus Coagulans GBI-30, 6086

Interventions

Bacillus Coagulans GBI-30, 6086 DIETARY_SUPPLEMENT

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.

Milk Protein; Milk Protein and Probiotic

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenwood University: lead
• Increnovo, LLC: collaborator

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

Related Publications (1)

• Walden KE, Hagele AM, Orr LS, Gross KN, Krieger JM, Jager R, Kerksick CM. Probiotic BC30 Improves Amino Acid Absorption from Plant Protein Concentrate in Older Women. Probiotics Antimicrob Proteins. 2024 Feb;16(1):125-137. doi: 10.1007/s12602-022-10028-4. Epub 2022 Dec 14.

  PMID: 36515888 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Supplements blinded to participant and investigator by third party
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, crossover study design

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: November 20, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)