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Completed

NCT Number: NCT06355089

Intestinal Microbiota: Immunity, Recovery and Metabolic Health

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.

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Key information

Conditions

Healthy

Age range

17 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turku

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Comparator

Dietary Supplement

Low-protein milk product

Whey protein hydrolysate milk product

Dietary Supplement

Milk product with whey protein hydrolysate

Postbiotic and whey protein hydrolysate milk product

Dietary Supplement

Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Primary outcomes

  1. Concentrations of inflammatory markers from the blood samples

    Time frame: 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 outcomes

  1. Changes in the gut microbiota composition, diversity and function

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

    Gut microbiota composition and function in feces by metagenomics shotgun sequencing

  2. Weight of the participant

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

    Weight

  3. Waist circumference of the participant

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

    Waist circumference

  4. Infections during the intervention

    Time frame: During intervention (Eight weeks)

    Self-reported infections during the intervention

  5. Development of physical fitness

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

    Based on walking test

  6. Changes in the sleep quality

    Time frame: During intervention (Eight weeks)

    Monitoring sleep quality using a sports watch.

  7. Changes in recovery

    Time frame: During intervention (Eight weeks)

    Monitoring recovery using a sports watch.

  8. Blood pressure

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

    Blood pressure

  9. BMI

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

    Body Mass Index (BMI)

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Government Body Funding

Registry information

Acronym: VAR-MIKRO

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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