Dietary Fiber and Gut Microbiome Study

NCT05424640 | Completed

• 1 other identifier: RTKU
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Gut microbiome; food diary; dietary fibers

Outcome Measures

Primary Outcomes (5)

• Evaluation of the intestinal microbiota

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

  150 days

• Evaluation of food consumption data

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

  150 days

• Evaluation of blood lipid profile

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

  150 days

• Evaluation of blood glucose levels

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

  150

• Evaluation of liver characteristics profile

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

  150

Secondary Outcomes (3)

• Evaluation of the stool form

  150 days

• Evaluation of the defecation frequency

  150

• Evaluation of the gastrointestinal symptoms

  150

Study Arms (9)

Baseline

NO INTERVENTION

Collection of baseline data 1 week before intervention

Dietary fiber 1

EXPERIMENTAL

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

Dietary Supplement: Dietary fiber 1

Wash-out 1

NO INTERVENTION

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

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

Dietary Supplement: Dietary fiber 2

Wash-out 2

NO INTERVENTION

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

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

Dietary Supplement: Dietary fiber 3

Wash-out 3

NO INTERVENTION

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

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

Dietary Supplement: Dietary fiber 4

Wash-out 4

NO INTERVENTION

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

Interventions

Dietary fiber 1 DIETARY_SUPPLEMENT

Description in the arm description

Dietary fiber 1

Dietary fiber 2 DIETARY_SUPPLEMENT

Description in the arm description

Dietary fiber 2

Dietary fiber 3 DIETARY_SUPPLEMENT

Description in the arm description

Dietary fiber 3

Dietary fiber 4 DIETARY_SUPPLEMENT

Description in the arm description

Dietary fiber 4

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center of Food and Fermentation Technologies: lead

Study Sites (1)

Center of Food and Fermentation Technologies

Tallinn, Harju, 12618, Estonia

Location

Study Officials

• Kaarel Adamberg, PhD

  Center of Food and Fermentation Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)