Intestinal Microbiota: Immunity, Recovery and Metabolic Health

University of Turku160 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

160

Conditions

Healthy

Interventions

Placebo ComparatorDIETARY_SUPPLEMENT

Low-protein milk product

Whey protein hydrolysate milk productDIETARY_SUPPLEMENT

Milk product with whey protein hydrolysate

Postbiotic and whey protein hydrolysate milk productDIETARY_SUPPLEMENT

Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Eligibility

Sex: ALLMin age: 17 YearsMax age: 28 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Turku

Turku, Finland

Outcomes

Primary Outcomes

Concentrations of inflammatory markers from the blood samples

hs-CRP (High-Sensitivity C-Reactive Protein), haptoglobin, suPAR (soluble urokinase-type Plasminogen Activator Receptor)

Time frame: At the baseline (week 0) and after eight weeks (last visit)

Secondary Outcomes

Changes in the gut microbiota composition, diversity and function

Gut microbiota composition and function in feces by metagenomics shotgun sequencing

Time frame: At the baseline (week 0) and after eight weeks (last visit)

Weight of the participant

Weight

Time frame: At the baseline (week 0), at four weeks and after eight weeks (last visit)

Waist circumference of the participant

Waist circumference

Time frame: At the baseline (week 0) and after eight weeks (last visit)

Infections during the intervention

Self-reported infections during the intervention

Time frame: During intervention (Eight weeks)

Development of physical fitness

Based on walking test

Time frame: At the baseline (week 0) and after eight weeks (last visit)

Changes in the sleep quality

Monitoring sleep quality using a sports watch.

Time frame: During intervention (Eight weeks)

Changes in recovery

Monitoring recovery using a sports watch.

Data from ClinicalTrials.gov

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