Dietary Fiber and Gut Microbiome Study

Center of Food and Fermentation Technologies

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Dietary fiber 3; Dietary Supplement: Dietary fiber 1; Dietary Supplement: Dietary fiber 4; Dietary Supplement: Dietary fiber 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05424640

RTKU

Details and patient eligibility

About

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.

Full description

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

1. Complete preliminary 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

1-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1. 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

1. Record food intake and gastrointestinal symptoms for 7 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

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

1. Baseline mapping (health questionnaire, 1 week food diary before sampling of blood and gut microbiota)
2. Dietary fiber 1, 3 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
3. Wash-out period, 2 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
4. 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.

Enrollment: 15 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 9 patient groups

Baseline

No Intervention group

Description:

Collection of baseline data 1 week before intervention

Dietary fiber 1

Experimental group

Description:

15 g/day oat fiber 3 weeks intervention At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Treatment:

Dietary Supplement: Dietary fiber 1

Wash-out 1

No Intervention group

Description:

2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Dietary fiber 2

Experimental group

Description:

15 g/day dietary fiber mix I 3 weeks intervention At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Treatment:

Dietary Supplement: Dietary fiber 2

Wash-out 2

No Intervention group

Description:

2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Dietary fiber 3

Experimental group

Description:

15 g/day dietary fiber 3 3 weeks intervention At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Treatment:

Dietary Supplement: Dietary fiber 3

Wash-out 3

No Intervention group

Description:

2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Dietary fiber 4

Experimental group

Description:

15 g/day rye fiber 3 weeks intervention At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Treatment:

Dietary Supplement: Dietary fiber 4

Wash-out 4

No Intervention group

Description:

2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire