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

Primary Purpose

Protein Malabsorption

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bacillus Coagulans GBI-30, 6086

About this trial

This is an interventional other trial for Protein Malabsorption

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Lindenwood University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Milk Protein

Milk Protein and Probiotic

Arm Description

25-gram dose of milk protein concentrate

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

Outcomes

Primary Outcome Measures

Plasma Concentrations of Amino Acids in Blood

Secondary Outcome Measures

Adverse Events

Incidence and associations of reported adverse events

Full Information

NCT ID

NCT05313178

First Posted

March 29, 2022

Last Updated

March 29, 2022

Sponsor

Lindenwood University

Collaborators

Increnovo, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05313178

Brief Title

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

Acronym

ABC

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 20, 2020 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lindenwood University

Collaborators

Increnovo, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Protein Malabsorption

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized, double-blind, crossover study design

Masking

ParticipantInvestigator

Masking Description

Supplements blinded to participant and investigator by third party

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Milk Protein

Arm Type

Placebo Comparator

Arm Description

25-gram dose of milk protein concentrate

Arm Title

Milk Protein and Probiotic

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Bacillus Coagulans GBI-30, 6086

Intervention Description

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.

Primary Outcome Measure Information:

Title

Plasma Concentrations of Amino Acids in Blood

Description

Plasma Concentrations of Amino Acids in Blood

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Incidence and associations of reported adverse events

Time Frame

4 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Lindenwood University

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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