Clinical trial NCT06355089: Intestinal Microbiota: Immunity, Recovery and Metabolic Health
Official title: Intestinal Microbiota: Immunity, Recovery and Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Nutrition
Probiotics
Whey protein
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Government Body Funding
First posted: 2024-04-09
Enrollment: 160
Sex: ALL
Minimum age (years): 17
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentrations of inflammatory markers from the blood samples
timeFrame: At the baseline (week 0) and after eight weeks (last visit)
Secondary outcomes:
measure: Changes in the gut microbiota composition, diversity and function
timeFrame: At the baseline (week 0) and after eight weeks (last visit)
measure: Weight of the participant
timeFrame: At the baseline (week 0), at four weeks and after eight weeks (last visit)
measure: Waist circumference of the participant
timeFrame: At the baseline (week 0) and after eight weeks (last visit)
measure: Infections during the intervention
timeFrame: During intervention (Eight weeks)
measure: Development of physical fitness
timeFrame: At the baseline (week 0) and after eight weeks (last visit)
measure: Changes in the sleep quality
timeFrame: During intervention (Eight weeks)
measure: Changes in recovery
timeFrame: During intervention (Eight weeks)
measure: Blood pressure
timeFrame: At the baseline (week 0), at four weeks and after eight weeks (last visit)
measure: BMI
timeFrame: At the baseline (week 0), at four weeks and after eight weeks (last visit)
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: University of Turku
name: Kirsi Laitinen, Professor
role: PRINCIPAL_INVESTIGATOR
References: