Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans
NCT ID: NCT03037918
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2017-02-03
2018-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
Yakult light
A fermented milk drink containing the probiotic Lactobacillus casei Shirota
Control Group
Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.
No interventions assigned to this group
Interventions
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Yakult light
A fermented milk drink containing the probiotic Lactobacillus casei Shirota
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
30 Years
ALL
Yes
Sponsors
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Yakult Honsha Co., LTD
INDUSTRY
Loughborough University
OTHER
Responsible Party
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Carl Hulston
Lecturer in Sports Nutrition
Principal Investigators
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Carl J Hulston
Role: PRINCIPAL_INVESTIGATOR
Loughborough University
Locations
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Loughborough University
Loughborough, Leicestershire, United Kingdom
Countries
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Other Identifiers
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R16-P132
Identifier Type: -
Identifier Source: org_study_id
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