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Completed

NCT Number: NCT05424640

Dietary Fiber and Gut Microbiome Study

The purpose of this dietary intervention is to study the effects of several dietary fibers on the gut microbiota at the personal level. Hypothesis 1: Intake of specific dietary fibers improves the blood lipid profile depending on the personal microbiota of the participants.

Hypothesis 2: detailed food intake analysis and continuous monitoring of gut microbiota enables to draw causative interrelationships between food components, bacteria of gut microbiome and health characteristics.

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Key information

Conditions

Age range

20 year–60 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 cross-over, pre-post intervention trial. All participants are enrolled into all study periods. Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs.

The main goal of this study was to elucidate the patterns between individual dietary fibers and gut microbiota at the personal level. Each person has a unique (individual) intestinal microbiological profile that changes according to lifestyle (diet, environment, physical activity), age and health status. With next generation sequencing methods to map microbial communities and detailed nutritional analysis including blood tests, it is possible to identify the specific effects of specific fiber on a selected (individual) microbiota. TFTAK researchers have long-term experience in microbiota analysis as well as diet design and nutrition analysis, which can be successfully applied in this project.

PRELIMINARY STUDY EVALUATION AND TESTING

  • Complete preliminary 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

1-WEEK QUESTIONNAIRE AND LABORATORY VISIT

  • Record food intake and gastrointestinal function for 7 days 2. Collect health data and provide a 7-day food diary using web-based program Nutridata (tap.nutridata.ee) 3. Provide a stool and blood sample at the laboratory 3-WEEK QUESTIONNAIRE AND

LABORATORY VISITS

  • Record food intake and gastrointestinal symptoms for 7 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

Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs:

  • Baseline mapping (health questionnaire, 1 week food diary before sampling of blood and gut microbiota)
  • Dietary fiber 1, 3 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
  • Wash-out period, 2 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
  • Repeating 3 times periods of 2 and 3. In each dietary fiber period 15 g/day of oat fiber, rye fiber, mix I and mix II of dietary fibers are used as test compounds. Dietary fiber mix I and mix II are inulin, beta-glucan, polydextrose, citrus pectin and psyllium, and beta-glucan, citrus pectin and psyllium, respectively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 20-60
  • Normal bowel function
  • Omnivorous diet
  • Ability to provide a signed written informed consent
  • Willing to provide stool and blood specimens over the 22-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

Dietary fiber 1

Dietary Supplement

Description in the arm description

Dietary fiber 2

Dietary Supplement

Description in the arm description

Dietary fiber 3

Dietary Supplement

Description in the arm description

Dietary fiber 4

Dietary Supplement

Description in the arm description

Primary outcomes

  1. Evaluation of the intestinal microbiota

    Time frame: 150 days

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

  2. Evaluation of food consumption data

    Time frame: 150 days

    All foods consumed were collected 1 week before the end of every study period using web-based program (tap.nutridata.ee)

  3. Evaluation of blood lipid profile

    Time frame: 150 days

    Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol after every intervention and wash-out in plasma (mmol/L).

  4. Evaluation of blood glucose levels

    Time frame: 150

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

  5. Evaluation of liver characteristics profile

    Time frame: 150

    Uric acid, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L).

Secondary outcomes

  1. Evaluation of the stool form

    Time frame: 150 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: 150

    • Evacuation frequency 7 days before every blood and microbiome sampling.
    • Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention.
  3. Evaluation of the gastrointestinal symptoms

    Time frame: 150

    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).

Sponsors and collaborators

Lead sponsor

Center of Food and Fermentation Technologies

Other

Registry information

Official study title

Intervention of Specific Dietary Fibers on Dynamics of Individual Gut Microbiota

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Feb 8, 2023

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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