Intestinal Microbiota: Immunity, Recovery and Metabolic Health (VAR-MIKRO)

University of Turku

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo Comparator; Dietary Supplement: Whey protein hydrolysate milk product; Dietary Supplement: Postbiotic and whey protein hydrolysate milk product

Study type: Interventional

Funder types: Other

Identifiers

NCT06355089

VAR-MIKRO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 17 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 3 patient groups, including a placebo group

Placebo milk product

Placebo Comparator group

Description:

Use of low protein milk product

Treatment:

Dietary Supplement: Placebo Comparator

Whey protein hydrolysate milk product

Active Comparator group

Description:

Use of milk product with whey protein hydrolysate

Treatment:

Dietary Supplement: Whey protein hydrolysate milk product

Postbiotic and whey protein hydrolysate milk product

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Postbiotic and whey protein hydrolysate milk product