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| Name | Class |
|---|---|
| Yakult Honsha Co., LTD | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yakult light | Dietary Supplement | A fermented milk drink containing the probiotic Lactobacillus casei Shirota |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Calculated from height and weight. | Day 0, Day 21 and Day 28 |
| Fasting plasma glucose concentration | Measured in fasting plasma sample. |
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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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl J Hulston | Loughborough University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loughborough University | Loughborough | Leicestershire | LE11 3TU | United Kingdom |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Open label, control trial
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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.
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| Day 0, Day 21 and Day 28 |
| Fasting serum insulin concentration | Measured in fasting serum sample. | Day 0, Day 21 and Day 28 |
| Fasting plasma triglyceride concentration | Measured in fasting plasma sample. | Day 0, Day 21 and Day 28 |
| Metabolic endotoxaemia | Plasma markers of endotoxaemia | Day 0, Day 21 and Day 28 |
| Markers of systemic inflammation | Selected plasma cytokines and chemokines | Day 0, Day 21 and Day 28 |
| Incretin response to glucose ingestion | GLP-1 | Day 0, Day 21 and Day 28 |
| Microbiome analysis | Faecal DNA analysis of the gut microbiota | Day 0, Day 21 and Day 28 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |