The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Test product; Dietary supplement: Control product

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Harjumaa
    • Tallinn, Harjumaa, Estonia, 12618
      • Center of Food and Fermentation Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Healthy adults consuming test product	Dietary supplement: Test product; 200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
Placebo Comparator: Control group; Healthy adults consuming control product	Dietary supplement: Control product; 200 g/day of unsweetened yogurt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the intestinal microbiota	Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.	14 days
Evaluation of blood lipid profile	Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).	14 days
Evaluation of blood glucose levels	Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the stool form	Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention.	14 days
Evaluation of the defecation frequency	Evacuation frequency during 3 days pre- and post-dietary intervention.; Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention.	14 days
Evaluation of the defecation timing	Evacuation timing 3 days before sampling pre- and post-dietary intervention.	14 days
Evaluation of the gastrointestinal symptoms	Frequency and severity of the gastrointestinal symptoms (Constipation, Diarrhea, Bloating, Flatulence, Cramps, Stomach pain). Scale of frequency: Never, Less than 10 times a year, Once a month, Once a week, Every day. Scale of severity: I do not have any gastrointestinal symptoms, Mild (does not disturb), Moderate, Strong (disturbs considerably).	14 days
Evaluation of the blood vitamin D status	25-OH vitamin D pre- and post-dietary intervention in plasma.	14 days

Collaborators and Investigators

• Sponsor: Center of Food and Fermentation Technologies
• Collaborators: SYNLAB Eesti OÜ, Tallinn, Estonia; AS FARMI Piimatööstus, Jõhvi, Estonia
• Investigators: Principal Investigator: Madis Jaagura, MSc, TFTAK

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: microbiome; fermented dairy product; bifidobacteria
• Other Study ID Numbers: 2014-2020.4.02.19-0198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Anonymized participant data could be made available for subsequent analysis in the mentioned institution (TFTAK).

Data made public will include only aggregates or summaries of the collected data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No