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

Primary Purpose

Insulin Sensitivity, Insulin Resistance, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Yakult light
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Sensitivity focused on measuring Gut Microbiota, High Fat Diets, Probiotics, Glycaemic Control

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females
  • Aged 18-30
  • Physically active (exercising at least 3 times per week for more than 30 min at a time)
  • Non-smoker
  • Free from cardiovascular or metabolic disease
  • Weight stable for at least 6 months
  • Normal body mass index (BMI: 18.5-24.9 kg/m2)*

  • Compliant (i.e. understands and is willing, able and likely to comply with all study requirements)

    • Note: If BMI is >24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion.

Exclusion Criteria:

  • Using probiotic or prebiotic supplements within the previous 3 months
  • Vegetarians and vegans
  • Diagnosis of insulin resistance, pre-diabetes or full diabetes
  • Underweight (determined as BMI less than 18.5 kg/m2)
  • Overweight or obese (determined as BMI greater than 24.9 kg/m2)
  • Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet.
  • Those who are unwilling to restrict their intake of fermented dairy products.
  • Those with known or suspected food intolerances, allergies or hypersensitivity
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
  • Participation in another clinical trial
  • Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months.
  • Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months.
  • Participants who know they would not be available for all the lab visits during the 4-week study period.

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Participants will receive 2 x 65mL doses of Yakult light per day, for 28 days. Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.

Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.

Outcomes

Primary Outcome Measures

Whole body insulin sensitivity index
Assessed by oral glucose tolerance test.

Secondary Outcome Measures

Body Mass Index
Calculated from height and weight.
Fasting plasma glucose concentration
Measured in fasting plasma sample.
Fasting serum insulin concentration
Measured in fasting serum sample.
Fasting plasma triglyceride concentration
Measured in fasting plasma sample.
Metabolic endotoxaemia
Plasma markers of endotoxaemia
Markers of systemic inflammation
Selected plasma cytokines and chemokines
Incretin response to glucose ingestion
GLP-1
Microbiome analysis
Faecal DNA analysis of the gut microbiota

Full Information

First Posted
January 26, 2017
Last Updated
October 30, 2018
Sponsor
Loughborough University
Collaborators
Yakult Honsha Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT03037918
Brief Title
Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans
Official Title
Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
Yakult Honsha Co., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Insulin Resistance, Type 2 Diabetes Mellitus
Keywords
Gut Microbiota, High Fat Diets, Probiotics, Glycaemic Control

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label, control trial
Masking
None (Open Label)
Masking Description
Participants will be given a unique identifier, which will not disclose the treatment group. All biological samples will be labelled with only the unique identifier.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants will receive 2 x 65mL doses of Yakult light per day, for 28 days. Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yakult light
Intervention Description
A fermented milk drink containing the probiotic Lactobacillus casei Shirota
Primary Outcome Measure Information:
Title
Whole body insulin sensitivity index
Description
Assessed by oral glucose tolerance test.
Time Frame
The change between pre- and post-high fat diet (assessed on days 21 and 28)
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Calculated from height and weight.
Time Frame
Day 0, Day 21 and Day 28
Title
Fasting plasma glucose concentration
Description
Measured in fasting plasma sample.
Time Frame
Day 0, Day 21 and Day 28
Title
Fasting serum insulin concentration
Description
Measured in fasting serum sample.
Time Frame
Day 0, Day 21 and Day 28
Title
Fasting plasma triglyceride concentration
Description
Measured in fasting plasma sample.
Time Frame
Day 0, Day 21 and Day 28
Title
Metabolic endotoxaemia
Description
Plasma markers of endotoxaemia
Time Frame
Day 0, Day 21 and Day 28
Title
Markers of systemic inflammation
Description
Selected plasma cytokines and chemokines
Time Frame
Day 0, Day 21 and Day 28
Title
Incretin response to glucose ingestion
Description
GLP-1
Time Frame
Day 0, Day 21 and Day 28
Title
Microbiome analysis
Description
Faecal DNA analysis of the gut microbiota
Time Frame
Day 0, Day 21 and Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females Aged 18-30 Physically active (exercising at least 3 times per week for more than 30 min at a time) Non-smoker Free from cardiovascular or metabolic disease Weight stable for at least 6 months Normal body mass index (BMI: 18.5-24.9 kg/m2)* Compliant (i.e. understands and is willing, able and likely to comply with all study requirements) Note: If BMI is >24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion. Exclusion Criteria: Using probiotic or prebiotic supplements within the previous 3 months Vegetarians and vegans Diagnosis of insulin resistance, pre-diabetes or full diabetes Underweight (determined as BMI less than 18.5 kg/m2) Overweight or obese (determined as BMI greater than 24.9 kg/m2) Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet. Those who are unwilling to restrict their intake of fermented dairy products. Those with known or suspected food intolerances, allergies or hypersensitivity Women who are known to be pregnant or who are intending to become pregnant over the course of the study. Participation in another clinical trial Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months. Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months. Participants who know they would not be available for all the lab visits during the 4-week study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J Hulston
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

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

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