Intestinal Microbiota: Immunity, Recovery and Metabolic Health

NCT06355089 | Completed

• 1 other identifier: VAR-MIKRO
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Nutrition; Probiotics; Whey protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Changes in the gut microbiota composition, diversity and function

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

• Weight of the participant

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

• Waist circumference of the participant

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

• Infections during the intervention

  During intervention (Eight weeks)

• Development of physical fitness

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

Study Arms (3)

Placebo milk product

PLACEBO COMPARATOR

Use of low protein milk product

Dietary Supplement: Placebo Comparator

Whey protein hydrolysate milk product

ACTIVE COMPARATOR

Use of milk product with whey protein hydrolysate

Dietary Supplement: Whey protein hydrolysate milk product

Postbiotic and whey protein hydrolysate milk product

ACTIVE COMPARATOR

Use of milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Dietary Supplement: Postbiotic and whey protein hydrolysate milk product

Interventions

Placebo Comparator DIETARY_SUPPLEMENT

Low-protein milk product

Placebo milk product

Whey protein hydrolysate milk product DIETARY_SUPPLEMENT

Milk product with whey protein hydrolysate

Whey protein hydrolysate milk product

Postbiotic and whey protein hydrolysate milk product DIETARY_SUPPLEMENT

Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Postbiotic and whey protein hydrolysate milk product

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead
• Government Body Funding: collaborator

Study Sites (1)

University of Turku

Turku, Finland

Location

Study Officials

• Kirsi Laitinen, Professor

  University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 9, 2024
• Study Start: January 9, 2023
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)