HealthyVAR-MIKRONCT06355089
Intestinal Microbiota: Immunity, Recovery and Metabolic Health
A study testing Whey protein hydrolysate milk product and Postbiotic and whey protein hydrolysate milk product in people with Healthy, run by University of Turku at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 17 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Whey protein hydrolysate milk product and Postbiotic and whey protein hydrolysate milk product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- 9 Jan 2023to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Placebo Comparator, Whey protein hydrolysate milk product, Postbiotic and whey protein hydrolysate milk product
- Keywords
- Nutrition, Probiotics, Whey protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ComparatorDietary supplement
Low-protein milk product
Whey protein hydrolysate milk productDietary supplement
Milk product with whey protein hydrolysate
Postbiotic and whey protein hydrolysate milk productDietary supplement
Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG
| Study group | Role | What they receive |
|---|---|---|
| Placebo milk product | Placebo comparator | Use of low protein milk product Receives: Dietary Supplement: Placebo Comparator |
| Whey protein hydrolysate milk product | Active comparator | Use of milk product with whey protein hydrolysate Receives: 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 Receives: Dietary Supplement: Postbiotic and whey protein hydrolysate milk product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of inflammatory markers from the blood samples
hs-CRP (High-Sensitivity C-Reactive Protein), haptoglobin, suPAR (soluble urokinase-type Plasminogen Activator Receptor)
Measured: At the baseline (week 0) and after eight weeks (last visit)
Secondary outcomes (9)
Changes in the gut microbiota composition, diversity and function
Gut microbiota composition and function in feces by metagenomics shotgun sequencing
Measured: At the baseline (week 0) and after eight weeks (last visit)
Weight of the participant
Weight
Measured: At the baseline (week 0), at four weeks and after eight weeks (last visit)
Waist circumference of the participant
Waist circumference
Measured: At the baseline (week 0) and after eight weeks (last visit)
Infections during the intervention
Self-reported infections during the intervention
Measured: During intervention (Eight weeks)
Development of physical fitness
Based on walking test
Measured: At the baseline (week 0) and after eight weeks (last visit)
Changes in the sleep quality
Monitoring sleep quality using a sports watch.
Measured: During intervention (Eight weeks)
Changes in recovery
Monitoring recovery using a sports watch.
Measured: During intervention (Eight weeks)
Blood pressure
Blood pressure
Measured: At the baseline (week 0), at four weeks and after eight weeks (last visit)
BMI
Body Mass Index (BMI)
Measured: At the baseline (week 0), at four weeks and after eight weeks (last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start9 Jan 2023
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Government Body Funding
- Responsible party
- Principal investigator, Kirsi Laitinen, University of Turku
- Investigators
- Kirsi Laitinen, Professor, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355089
- Sponsor's protocol ID
- VAR-MIKRO
- Acronym
- VAR-MIKRO
- Status last verified
- May 2024
- First submitted
- 21 Mar 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otto S, Janina H, Janne A, Karoliina H, Kati M, Jenni P, Tero V, Turpeinen A, Juhani N, Seppo S, Kirsi L. Effect of hydrolyzed milk proteins and postbiotic Lacticaseibacillus rhamnosus GG on inflammatory responses in conscripts: A randomized double-blind pilot trial. Clin Nutr ESPEN. 2026 Sep 12:105109. doi: 10.1016/j.clnesp.2026.105109. Online ahead of print.
PubMed 42731724
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota: Immunity, Recovery and Metabolic Health
- ClinicalTrials.gov ID
- NCT06355089
- Acronym / sponsor ID
- VAR-MIKRO / VAR-MIKRO
- Conditions
- Healthy
- Keywords
- Nutrition, Probiotics, Whey protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Government Body Funding
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo milk product | Placebo comparator | Dietary Supplement: Placebo ComparatorUse of low protein milk product |
| Whey protein hydrolysate milk product | Active comparator | Dietary Supplement: Whey protein hydrolysate milk productUse of milk product with whey protein hydrolysate |
| Postbiotic and whey protein hydrolysate milk product | Active comparator | Dietary Supplement: Postbiotic and whey protein hydrolysate milk productUse of milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo ComparatorLow-protein milk product | Dietary supplement | Placebo milk product |
| Whey protein hydrolysate milk productMilk product with whey protein hydrolysate | Dietary supplement | Whey protein hydrolysate milk product |
| Postbiotic and whey protein hydrolysate milk productMilk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG | Dietary supplement | Postbiotic and whey protein hydrolysate milk product |
Primary outcome
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)
9 secondary outcomes
Changes in the gut microbiota composition, diversity and function
Time frame: At the baseline (week 0) and after eight weeks (last visit)
Weight of the participant
Time frame: At the baseline (week 0), at four weeks and after eight weeks (last visit)
Waist circumference of the participant
Time frame: At the baseline (week 0) and after eight weeks (last visit)
Infections during the intervention
Time frame: During intervention (Eight weeks)
Development of physical fitness
Time frame: At the baseline (week 0) and after eight weeks (last visit)
Changes in the sleep quality
Time frame: During intervention (Eight weeks)
Changes in recovery
Time frame: During intervention (Eight weeks)
Blood pressure
Time frame: At the baseline (week 0), at four weeks and after eight weeks (last visit)
BMI
Time frame: At the baseline (week 0), at four weeks and after eight weeks (last visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 42731724Otto S, Janina H, Janne A, Karoliina H, Kati M, Jenni P, Tero V, Turpeinen A, Juhani N, Seppo S, Kirsi L. Effect of hydrolyzed milk proteins and postbiotic Lacticaseibacillus rhamnosus GG on inflammatory responses in conscripts: A randomized double-blind pilot trial. Clin Nutr ESPEN. 2026 Sep 12:105109. doi: 10.1016/j.clnesp.2026.105109. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi Laitinen, Professor principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein hydrolysate milk product and Postbiotic and whey protein hydrolysate milk product in people with Healthy, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of inflammatory markers from the blood samples (time frame: At the baseline (week 0) and after eight weeks (last visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.