Dietary Fiber and Gut Microbiome Study

• Sponsor: Center of Food and Fermentation Technologies (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05424640
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 9
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Dietary fiber 1; Dietary Supplement: Dietary fiber 2; Dietary Supplement: Dietary fiber 3; Dietary Supplement: Dietary fiber 4	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Intervention of Specific Dietary Fibers on Dynamics of Individual Gut Microbiota
• Actual Study Start Date: Feb 1, 2022
• Actual Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Baseline Collection of baseline data 1 week before intervention
Experimental: Dietary fiber 1 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; Description in the arm description
No Intervention: Wash-out 1 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire
Experimental: Dietary fiber 2 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; Description in the arm description
No Intervention: Wash-out 2 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire
Experimental: Dietary fiber 3 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; Description in the arm description
No Intervention: Wash-out 3 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire
Experimental: Dietary fiber 4 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; Description in the arm description
No Intervention: Wash-out 4 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire

Outcome Measures

Primary Outcome Measures

1. Evaluation of the intestinal microbiota [150 days]

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

2. Evaluation of food consumption data [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 [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 [150]

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

5. Evaluation of liver characteristics profile [150]

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

Secondary Outcome Measures

1. Evaluation of the stool form [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 [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Food and Fermentation Technologies	Tallinn	Harjumaa	Estonia	12618

Sponsors and Collaborators

• Center of Food and Fermentation Technologies

Investigators

• Principal Investigator: Kaarel Adamberg, PhD, Center of Food and Fermentation Technologies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaarel Adamberg, Project manager, Center of Food and Fermentation Technologies
• ClinicalTrials.gov Identifier: NCT05424640
• Other Study ID Numbers: RTKU
• First Posted: Jun 21, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaarel Adamberg, Project manager, Center of Food and Fermentation Technologies: Gut microbiome; food diary; dietary fibers

Study Results

No Results Posted as of Jul 20, 2022