Intestinal Microbiota: Immunity, Recovery and Metabolic Health

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Whey protein hydrolysate milk product; Dietary Supplement: Placebo Comparator; Dietary Supplement: Postbiotic and whey protein hydrolysate milk product

• Registration Number: NCT06355089
• Lead Sponsor: University of Turku

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.

Study Timeline

• Study Start: 2023-01-09
• Primary Completion: 2023-09-07
• Study Completion: 2023-09-07
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whey protein hydrolysate milk product	Whey protein hydrolysate milk product	Use of milk product with whey protein hydrolysate
Placebo milk product	Placebo Comparator	Use of low protein milk product
Postbiotic and whey protein hydrolysate milk product	Postbiotic and whey protein hydrolysate milk product	Use of milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Primary Outcome Measures

Name	Time	Method
Concentrations of inflammatory markers from the blood samples	At 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 Outcome Measures

Name	Time	Method
Waist circumference of the participant	At the baseline (week 0) and after eight weeks (last visit)	Waist circumference
Changes in recovery	During intervention (Eight weeks)	Monitoring recovery using a sports watch.
Development of physical fitness	At the baseline (week 0) and after eight weeks (last visit)	Based on walking test
Blood pressure	At the baseline (week 0), at four weeks and after eight weeks (last visit)	Blood pressure
Infections during the intervention	During intervention (Eight weeks)	Self-reported infections during the intervention
Changes in the sleep quality	During intervention (Eight weeks)	Monitoring sleep quality using a sports watch.
Changes in the gut microbiota composition, diversity and function	At the baseline (week 0) and after eight weeks (last visit)	Gut microbiota composition and function in feces by metagenomics shotgun sequencing
Weight of the participant	At the baseline (week 0), at four weeks and after eight weeks (last visit)	Weight
BMI	At the baseline (week 0), at four weeks and after eight weeks (last visit)	Body Mass Index (BMI)

Trial Locations

Locations (1)

University of Turku; 🇫🇮 Turku, Finland