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Completed

NCT Number: NCT04811157

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.

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Key information

Conditions

Healthy

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Food and Fermentation Technologies

Tallinn, Harju, 12618, Estonia

About this study

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

  • Complete pre-study questionnaire
  • Complete orientation to the study and provide voluntary consent to join the study
  • Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
  • 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
  • Record food intake and gastrointestinal symptoms for 3 days
  • Collect health data and provide a 3-day food frequency questionnaire
  • Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES
  • Provide the blood sample at the laboratory in the morning in an overnight fasted state.

DIETARY INTERVENTION

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test product

Dietary Supplement

200 g/day of unsweetened yogurt supplemented with a dietary fiber blend

Control product

Dietary Supplement

200 g/day of unsweetened yogurt

Primary outcomes

  1. Evaluation of the intestinal microbiota

    Time frame: 14 days

    Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.

  2. Evaluation of blood lipid profile

    Time frame: 14 days

    Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).

  3. Evaluation of blood glucose levels

    Time frame: 14 days

    Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).

Secondary outcomes

  1. Evaluation of the stool form

    Time frame: 14 days

    Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention.

  2. Evaluation of the defecation frequency

    Time frame: 14 days

    • Evacuation frequency during 3 days pre- and post-dietary intervention.
    • Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention.

  3. Evaluation of the defecation timing

    Time frame: 14 days

    Evacuation timing 3 days before sampling pre- and post-dietary intervention.

  4. Evaluation of the gastrointestinal symptoms

    Time frame: 14 days

    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).

  5. Evaluation of the blood vitamin D status

    Time frame: 14 days

    25-OH vitamin D pre- and post-dietary intervention in plasma.

Sponsors and collaborators

Lead sponsor

Center of Food and Fermentation Technologies

Other

Collaborators

  • AS FARMI Piimatööstus, Jõhvi, Estonia
  • SYNLAB Eesti OÜ, Tallinn, Estonia

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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