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Intestinal Microbiota: Immunity, Recovery and Metabolic Health

Intestinal Microbiota: Immunity, Recovery and Metabolic Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06355089
Acronym
VAR-MIKRO
Enrollment
160
Registered
2024-04-09
Start date
2023-01-09
Completion date
2023-09-07
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Nutrition, Probiotics, Whey protein

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTPlacebo Comparator

Low-protein milk product

DIETARY_SUPPLEMENTWhey protein hydrolysate milk product

Milk product with whey protein hydrolysate

DIETARY_SUPPLEMENTPostbiotic and whey protein hydrolysate milk product

Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Sponsors

Government Body Funding
CollaboratorUNKNOWN
University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
17 Years to 28 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Concentrations of inflammatory markers from the blood samplesAt the baseline (week 0) and after eight weeks (last visit)hs-CRP (High-Sensitivity C-Reactive Protein), haptoglobin, suPAR (soluble urokinase-type Plasminogen Activator Receptor)

Secondary

MeasureTime frameDescription
Weight of the participantAt the baseline (week 0), at four weeks and after eight weeks (last visit)Weight
Waist circumference of the participantAt the baseline (week 0) and after eight weeks (last visit)Waist circumference
Infections during the interventionDuring intervention (Eight weeks)Self-reported infections during the intervention
Development of physical fitnessAt the baseline (week 0) and after eight weeks (last visit)Based on walking test
Changes in the gut microbiota composition, diversity and functionAt the baseline (week 0) and after eight weeks (last visit)Gut microbiota composition and function in feces by metagenomics shotgun sequencing
Changes in recoveryDuring intervention (Eight weeks)Monitoring recovery using a sports watch.
Blood pressureAt the baseline (week 0), at four weeks and after eight weeks (last visit)Blood pressure
BMIAt the baseline (week 0), at four weeks and after eight weeks (last visit)Body Mass Index (BMI)
Changes in the sleep qualityDuring intervention (Eight weeks)Monitoring sleep quality using a sports watch.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 14, 2026