Intestinal Microbiota: Immunity, Recovery and Metabolic Health

Healthy Clinical Trial

— VAR-MIKRO  

Official title:

Intestinal Microbiota: Immunity, Recovery and Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06355089
• Other study ID #: VAR-MIKRO
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: September 7, 2023

Study information

• Verified date: May 2024
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Placebo Comparator
Low-protein milk product
• Whey protein hydrolysate milk product
Milk product with whey protein hydrolysate
• Postbiotic and whey protein hydrolysate milk product
Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Government Body Funding

Country where clinical trial is conducted

Finland, 

Outcome

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