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Completed

NCT Number: NCT03037918

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

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.

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Key information

Conditions

Insulin Sensitivity Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yakult light

Dietary Supplement

A fermented milk drink containing the probiotic Lactobacillus casei Shirota

Primary outcomes

  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 outcomes

  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

    GLP-1

  8. Microbiome analysis

    Time frame: Day 0, Day 21 and Day 28

    Faecal DNA analysis of the gut microbiota

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • Yakult Honsha Co., LTD

Registry information

Official study title

Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2017
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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