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Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers

NCT02215343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-05-20

No results posted yet for this study

Summary

The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.

Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.

Conditions

Interventions

DIETARY_SUPPLEMENT

Wheat bran extract

Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R\&D Centre Europe).

DIETARY_SUPPLEMENT

Fish oil

Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).

Sponsors & Collaborators

  • http://mynewgut.eu/partners

    collaborator UNKNOWN

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Lesli H Larsen, PhD · Department of Nutrition, Exercise and sports, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Denmark

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 NCT02215343 on ClinicalTrials.gov