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

NCT03037918 | Completed

• 1 other identifier: R16-P132
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity; Insulin Resistance; Type 2 Diabetes Mellitus

Keywords

Gut Microbiota; High Fat Diets; Probiotics; Glycaemic Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Body Mass Index

  Day 0, Day 21 and Day 28

• Fasting plasma glucose concentration

  Day 0, Day 21 and Day 28

• Fasting serum insulin concentration

  Day 0, Day 21 and Day 28

• Fasting plasma triglyceride concentration

  Day 0, Day 21 and Day 28

• Metabolic endotoxaemia

  Day 0, Day 21 and Day 28

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.

Interventions

Yakult light DIETARY_SUPPLEMENT

A fermented milk drink containing the probiotic Lactobacillus casei Shirota

Treatment Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loughborough University: lead
• Yakult Honsha Co., LTD: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Carl J Hulston

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Sports Nutrition

Model Details: Open label, control trial

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: February 3, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

GB (1)