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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037918
• Other study ID #: R16-P132
• Status: Completed
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Insulin Sensitivity
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
Loughborough University	Yakult Honsha Co., LTD

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body insulin sensitivity index	Assessed by oral glucose tolerance test.	The change between pre- and post-high fat diet (assessed on days 21 and 28)
Secondary	Body Mass Index	Calculated from height and weight.	Day 0, Day 21 and Day 28
Secondary	Fasting plasma glucose concentration	Measured in fasting plasma sample.	Day 0, Day 21 and Day 28
Secondary	Fasting serum insulin concentration	Measured in fasting serum sample.	Day 0, Day 21 and Day 28
Secondary	Fasting plasma triglyceride concentration	Measured in fasting plasma sample.	Day 0, Day 21 and Day 28
Secondary	Metabolic endotoxaemia	Plasma markers of endotoxaemia	Day 0, Day 21 and Day 28
Secondary	Markers of systemic inflammation	Selected plasma cytokines and chemokines	Day 0, Day 21 and Day 28
Secondary	Incretin response to glucose ingestion	GLP-1	Day 0, Day 21 and Day 28
Secondary	Microbiome analysis	Faecal DNA analysis of the gut microbiota	Day 0, Day 21 and Day 28