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Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans

NCT03037918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-10-31

No results posted yet for this study

Summary

Participants will be randomly allocated to either Yakult ingestion or a control group. For the first 20 days, subjects will consume their normal diet (keeping a detailed food diary throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.

The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic inflammation as well as decreasing whole body insulin sensitivity (as we have shown previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action / insulin sensitivity.

Conditions

Interventions

DIETARY_SUPPLEMENT

Yakult light

A fermented milk drink containing the probiotic Lactobacillus casei Shirota

Sponsors & Collaborators

  • Yakult Honsha Co., LTD

    collaborator INDUSTRY

  • Loughborough University

    lead OTHER

Principal Investigators

  • Carl J Hulston · Loughborough University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United Kingdom

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 NCT03037918 on ClinicalTrials.gov