Clinical trial NCT04811157: The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
Official title: The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: microbiome
bifidobacteria
fermented dairy product
Lead sponsor: Center of Food and Fermentation Technologies
Sponsor class: OTHER
Collaborators: name: SYNLAB Eesti OÜ, Tallinn, Estonia
name: AS FARMI Piimatööstus, Jõhvi, Estonia
First posted: 2021-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.

Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.

Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.

Detailed description: The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.

PRE-STUDY EVALUATION AND TESTING

1. Complete pre-study questionnaire
2. Complete orientation to the study and provide voluntary consent to join the study
3. Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1. Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1. Record food intake and gastrointestinal symptoms for 3 days
2. Collect health data and provide a 3-day food frequency questionnaire
3. Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES

1. Provide the blood sample at the laboratory in the morning in an overnight fasted state.

DIETARY INTERVENTION

1. Daily intake of a test or control product for two weeks.

Eligibility criteria: Inclusion Criteria:

* Age 25-55
* Normal bowel function
* Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
* Ability to provide a signed written informed consent
* Willing to provide stool and blood specimens 2 times over the 2-week study period

Exclusion Criteria:

* Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
* Medication: statins, blood pressure medications, antidepressants, other prescription medications
* History of bariatric operation, removal of the gallbladder.
* Food allergies, lactose intolerance
* Recent (previous 3 months) use of antibiotics
* Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
* Current pregnancy or breastfeeding
* Volunteers showing previously unrecognized illness will also be excluded
* Individual unable to give informed consent

Primary outcomes:
measure: Evaluation of the intestinal microbiota
timeFrame: 14 days
measure: Evaluation of blood lipid profile
timeFrame: 14 days
measure: Evaluation of blood glucose levels
timeFrame: 14 days
Secondary outcomes:
measure: Evaluation of the stool form
timeFrame: 14 days
measure: Evaluation of the defecation frequency
timeFrame: 14 days
measure: Evaluation of the defecation timing
timeFrame: 14 days
measure: Evaluation of the gastrointestinal symptoms
timeFrame: 14 days
measure: Evaluation of the blood vitamin D status
timeFrame: 14 days
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Center of Food and Fermentation Technologies
state: Harjumaa
Study officials:
affiliation: TFTAK
name: Madis Jaagura, MSc
role: PRINCIPAL_INVESTIGATOR
References: