NCT04811157

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 18, 2021

Last Update Submit

March 19, 2021

Conditions

Healthy

Keywords

microbiomebifidobacteriafermented dairy product

Outcome Measures

Primary Outcomes (3)

  • Evaluation of the intestinal microbiota

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

    14 days

  • Evaluation of blood lipid profile

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

    14 days

  • Evaluation of blood glucose levels

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

    14 days

Secondary Outcomes (5)

  • Evaluation of the stool form

    14 days

  • Evaluation of the defecation frequency

    14 days

  • Evaluation of the defecation timing

    14 days

  • Evaluation of the gastrointestinal symptoms

    14 days

  • Evaluation of the blood vitamin D status

    14 days

Study Arms (2)

Test group

EXPERIMENTAL

Healthy adults consuming test product

Dietary Supplement: Test product

Control group

PLACEBO COMPARATOR

Healthy adults consuming control product

Dietary Supplement: Control product

Interventions

Test productDIETARY_SUPPLEMENT

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

Test group
Control productDIETARY_SUPPLEMENT

200 g/day of unsweetened yogurt

Control group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Food and Fermentation Technologies

Tallinn, Harju, 12618, Estonia

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Madis Jaagura, MSc

    TFTAK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 23, 2021

Study Start

April 1, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

ES(1)