Intestinal Microbiota: Immunity, Recovery and Metabolic Health (VAR-MIKRO)

The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo Comparator; Dietary supplement: Whey protein hydrolysate milk product; Dietary supplement: Postbiotic and whey protein hydrolysate milk product

Detailed Description

The study is a randomized, double-blind, 3-arm intervention involving young adults (n=160). Participants are randomized into three groups to receive different study product, and differences among the groups will be compared, for example, in terms of gut microbiota, weight changes, and inflammatory markers derived from blood samples.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • University of Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- healthy

Exclusion Criteria:

• medicines and diseases that significantly affect the functioning of the stomach and intestines (e.g. irritable bowel syndrome)
• antibiotic treatment within 3 months
• asthma medication
• milk allergy (protein); the study product is lactose-free
• the participant must adhere to avoid the use of foods or nutritional supplements containing probiotics, and high-protein products, e.g. whey protein powders and high-protein snack bars

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo milk product; Use of low protein milk product	Dietary supplement: Placebo Comparator; Low-protein milk product
Active Comparator: Whey protein hydrolysate milk product; Use of milk product with whey protein hydrolysate	Dietary supplement: Whey protein hydrolysate milk product; Milk product with whey protein hydrolysate
Active Comparator: Postbiotic and whey protein hydrolysate milk product; Use of milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG	Dietary supplement: Postbiotic and whey protein hydrolysate milk product; Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of inflammatory markers from the blood samples	hs-CRP (High-Sensitivity C-Reactive Protein), haptoglobin, suPAR (soluble urokinase-type Plasminogen Activator Receptor)	At the baseline (week 0) and after eight weeks (last visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota composition in feces	Gut microbiota composition and function	At the baseline (week 0) and after eight weeks (last visit)
Weight of the participant	Weight	At the baseline (week 0), at four weeks and after eight weeks (last visit)
Waist circumference of the participant	Waist circumference	At the baseline (week 0) and after eight weeks (last visit)
Infections during the intervention	Self-reported infections during the intervention	During intervention
Development of physical fitness	Based on walking test	At the baseline (week 0) and after eight weeks (last visit)
Sleep quality	Monitoring sleep quality using a sports watch.	During intervention
Recovery	Monitoring recovery using a sports watch.	During the intervention
Blood pressure	Blood pressure	At the baseline (week 0), at four weeks and after eight weeks (last visit)
BMI	Body Mass Index (BMI)	At the baseline (week 0), at four weeks and after eight weeks (last visit)

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Government Body Funding
• Investigators: Principal Investigator: Kirsi Laitinen, Professor, University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): September 7, 2023
• Study Completion (Actual): September 7, 2023

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; Nutrition; Whey protein
• Other Study ID Numbers: VAR-MIKRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No