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

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ClinicalTrials.gov Identifier: NCT03037918
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : October 31, 2018
Yakult Honsha Co., LTD
Information provided by (Responsible Party):
Carl Hulston, Loughborough University

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.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Insulin Resistance Type 2 Diabetes Mellitus Dietary Supplement: Yakult light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Basic Science
Official Title: Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Group

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.

Dietary Supplement: Yakult light
A fermented milk drink containing the probiotic Lactobacillus casei Shirota

No Intervention: Control Group
Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.

Primary Outcome Measures :
  1. Whole body insulin sensitivity index [ Time Frame: The change between pre- and post-high fat diet (assessed on days 21 and 28) ]
    Assessed by oral glucose tolerance test.

Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: Day 0, Day 21 and Day 28 ]
    Calculated from height and weight.

  2. Fasting plasma glucose concentration [ Time Frame: Day 0, Day 21 and Day 28 ]
    Measured in fasting plasma sample.

  3. Fasting serum insulin concentration [ Time Frame: Day 0, Day 21 and Day 28 ]
    Measured in fasting serum sample.

  4. Fasting plasma triglyceride concentration [ Time Frame: Day 0, Day 21 and Day 28 ]
    Measured in fasting plasma sample.

  5. Metabolic endotoxaemia [ Time Frame: Day 0, Day 21 and Day 28 ]
    Plasma markers of endotoxaemia

  6. Markers of systemic inflammation [ Time Frame: Day 0, Day 21 and Day 28 ]
    Selected plasma cytokines and chemokines

  7. Incretin response to glucose ingestion [ Time Frame: Day 0, Day 21 and Day 28 ]

  8. Microbiome analysis [ Time Frame: Day 0, Day 21 and Day 28 ]
    Faecal DNA analysis of the gut microbiota

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037918

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United Kingdom
Loughborough University
Loughborough, Leicestershire, United Kingdom, LE11 3TU
Sponsors and Collaborators
Loughborough University
Yakult Honsha Co., LTD
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Principal Investigator: Carl J Hulston Loughborough University
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Responsible Party: Carl Hulston, Lecturer in Sports Nutrition, Loughborough University
ClinicalTrials.gov Identifier: NCT03037918    
Other Study ID Numbers: R16-P132
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carl Hulston, Loughborough University:
Gut Microbiota
High Fat Diets
Glycaemic Control
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases