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Modification of Gut Microbiota in the Treatment of Insulin Resistance: a Personalized Approach

NCT03710850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-03-28

No results posted yet for this study

Summary

Gut microbiota may play a key role in many metabolic diseases, including type 2 diabetes (T2D). Consumption of high-fat/high-sugar western diet seem to alter human resident microbiota towards reduced genetic diversity and to influence its metabolic activity towards enhanced energy extraction. Plant-based diets are effective in the treatment of T2D but it is not clear whether their effect results solely from diet composition or whether it is mediated, at least partly, by different microbiota and its metabolic activity. One possible therapeutic approach is replacement of "pro-diabetic" microbiota with its "healthy" variant but what the "healthy" microbiota is and under which conditions this microbiota could stay stable and functional is not known. The aim of the proposed study is to identify possible metagenome/metabolome characteristics in different human cohorts (T2D vs vegans), to assess the stability of vegan microbiota in T2D-like environment and to evaluate the possibility to influence human T2D microbiota/metabolome towards more protective composition by dietary intervention.

Conditions

Interventions

DIETARY_SUPPLEMENT

Inulin

Inulin is a dietary fibre. Will be supplemented in a dose 10g/d for a period of 3 moths.

Sponsors & Collaborators

  • Institute for Clinical and Experimental Medicine

    collaborator OTHER_GOV

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Jan Gojda, MD, PhD · Third Faculty of Medicine Charles University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710850 on ClinicalTrials.gov