Clinical trial NCT03037918: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Insulin Resistance
Type 2 Diabetes Mellitus
Keywords: Gut Microbiota
High Fat Diets
Probiotics
Glycaemic Control
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2017-01-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, control trial
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Whole body insulin sensitivity index
timeFrame: The change between pre- and post-high fat diet (assessed on days 21 and 28)
Secondary outcomes:
measure: Body Mass Index
timeFrame: Day 0, Day 21 and Day 28
measure: Fasting plasma glucose concentration
timeFrame: Day 0, Day 21 and Day 28
measure: Fasting serum insulin concentration
timeFrame: Day 0, Day 21 and Day 28
measure: Fasting plasma triglyceride concentration
timeFrame: Day 0, Day 21 and Day 28
measure: Metabolic endotoxaemia
timeFrame: Day 0, Day 21 and Day 28
measure: Markers of systemic inflammation
timeFrame: Day 0, Day 21 and Day 28
measure: Incretin response to glucose ingestion
timeFrame: Day 0, Day 21 and Day 28
measure: Microbiome analysis
timeFrame: Day 0, Day 21 and Day 28
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Carl J Hulston
role: PRINCIPAL_INVESTIGATOR
References: