Intestinal Microbiota: Immunity, Recovery and Metabolic Health

NCT ID: NCT06355089

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2023-09-07

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo milk product

Use of low protein milk product

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DIETARY_SUPPLEMENT

Low-protein milk product

Whey protein hydrolysate milk product

Use of milk product with whey protein hydrolysate

Group Type ACTIVE_COMPARATOR

Whey protein hydrolysate milk product

Intervention Type DIETARY_SUPPLEMENT

Milk product with whey protein hydrolysate

Postbiotic and whey protein hydrolysate milk product

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

Group Type ACTIVE_COMPARATOR

Postbiotic and whey protein hydrolysate milk product

Intervention Type DIETARY_SUPPLEMENT

Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Interventions

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Placebo Comparator

Low-protein milk product

Intervention Type DIETARY_SUPPLEMENT

Whey protein hydrolysate milk product

Milk product with whey protein hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Postbiotic and whey protein hydrolysate milk product

Milk product with whey protein hydrolysate and Lacticaseibacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Body Funding

UNKNOWN

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Kirsi Laitinen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirsi Laitinen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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University of Turku

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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VAR-MIKRO

Identifier Type: -

Identifier Source: org_study_id

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