Insulin SensitivityNCT03037918
Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans
A study testing Yakult light in people with Insulin Sensitivity and Insulin Resistance, run by Loughborough University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Insulin Resistance, Type 2 Diabetes Mellitus
- What is being tested?
- Yakult light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.
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.
- Being tested
- Yakult light
- Keywords
- Gut Microbiota, High Fat Diets, Probiotics, Glycaemic Control
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yakult lightDietary supplement
A fermented milk drink containing the probiotic Lactobacillus casei Shirota
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body insulin sensitivity index
Assessed by oral glucose tolerance test.
Measured: The change between pre- and post-high fat diet (assessed on days 21 and 28)
Secondary outcomes (8)
Body Mass Index
Calculated from height and weight.
Measured: Day 0, Day 21 and Day 28
Fasting plasma glucose concentration
Measured in fasting plasma sample.
Measured: Day 0, Day 21 and Day 28
Fasting serum insulin concentration
Measured in fasting serum sample.
Measured: Day 0, Day 21 and Day 28
Fasting plasma triglyceride concentration
Measured in fasting plasma sample.
Measured: Day 0, Day 21 and Day 28
Metabolic endotoxaemia
Plasma markers of endotoxaemia
Measured: Day 0, Day 21 and Day 28
Markers of systemic inflammation
Selected plasma cytokines and chemokines
Measured: Day 0, Day 21 and Day 28
Incretin response to glucose ingestion
GLP-1
Measured: Day 0, Day 21 and Day 28
Microbiome analysis
Faecal DNA analysis of the gut microbiota
Measured: Day 0, Day 21 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start3 Feb 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, control trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Principal investigator, Carl Hulston, Loughborough University
- Investigators
- Carl J Hulston, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037918
- Sponsor's protocol ID
- R16-P132
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2017
- Last updated
- 31 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans. A Large-cohort, Mechanistic Follow-up Study.
- ClinicalTrials.gov ID
- NCT03037918
- Acronym / sponsor ID
- R16-P132
- Keywords
- Gut Microbiota, High Fat Diets, Probiotics, Glycaemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, control trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Yakult lightParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yakult lightA fermented milk drink containing the probiotic Lactobacillus casei Shirota | Dietary supplement | Treatment Group |
Primary outcome
Whole body insulin sensitivity index
Time frame: The change between pre- and post-high fat diet (assessed on days 21 and 28)
Assessed by oral glucose tolerance test.
8 secondary outcomes
Body Mass Index
Time frame: Day 0, Day 21 and Day 28
Fasting plasma glucose concentration
Time frame: Day 0, Day 21 and Day 28
Fasting serum insulin concentration
Time frame: Day 0, Day 21 and Day 28
Fasting plasma triglyceride concentration
Time frame: Day 0, Day 21 and Day 28
Metabolic endotoxaemia
Time frame: Day 0, Day 21 and Day 28
Markers of systemic inflammation
Time frame: Day 0, Day 21 and Day 28
Incretin response to glucose ingestion
Time frame: Day 0, Day 21 and Day 28
Microbiome analysis
Time frame: Day 0, Day 21 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
Related trials for Insulin Sensitivity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Hulston principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yakult light in people with Insulin Sensitivity and Insulin Resistance, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body insulin sensitivity index (time frame: The change between pre- and post-high fat diet (assessed on days 21 and 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.