Insulin ResistanceNCT03102463
The Role of Milk Derived Peptides on Glycaemic Control
A study testing Milk derived hydrolysate, Parent Protein and Lipid Load in people with Insulin Resistance, run by University College Dublin at 1 site in Ireland.
Trial summary
This study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. A comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Milk derived hydrolysate, Parent Protein and Lipid Load
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2015to Jun 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years
- BMI > 26 kg/m2
- Prepared to maintain a constant body weight for the duration of the study
- Free of any chronic or infectious disease
- Not taking any medication for the regulation of blood sugars
- Diet controlled type 2 diabetes
- Free of any milk allergies or lactose intolerance
- Without anaemia
Who cannot join
- <18 or >65 years
- Diabetes (pharmacologically treated) or other endocrine disorders.
- Chronic inflammatory conditions.
- Kidney or liver dysfunction.
- Anaemia (Haemoglobin <12g/dl men, < 11g/dl women).
- Taking any medication for the regulation of blood sugars.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. A comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve insulin resistance in cell and animal models. Therefore the investigators aim is to test their efficacy in overweight, insulin resistant individuals at risk of developing type 2 diabetes.
Read the detailed description
Recent figures estimate 60% of Irish adults are overweight or obese. As obesity is associated with the development of insulin resistance, which precedes type 2 diabetes development by decades, novel food based solutions are required to improve glycaemic control and attenuate insulin resistance.
In the current study insulin resistant individuals will undergo 4 study visits, 1 screening visit and 3 subsequent visits. At each of the 3 visits they will receive an oral lipid load consisting of 100mL soya bean oil, followed by either a water control; the hydrolysate being tested or the parent protein from which the hydrolysate was derived. After which they will undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin sensitivity.
- Conditions
- Insulin Resistance
- Being tested
- Water Control, Milk derived hydrolysate, Parent Protein, Lipid Load
- Keywords
- Insulin sensitivity, Obesity, Insulin resistance, Milk derived hydrolysate, Hyperinsulinemic-euglycaemic clamp
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water ControlDietary supplement
120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
Milk derived hydrolysateDietary supplement
Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Parent ProteinDietary supplement
Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
Lipid LoadOther
100mL oral lipid load
| Study group | Role | What they receive |
|---|---|---|
| Water Control | Sham comparator | Not described Receives: Dietary Supplement: Water Control; Other: Lipid Load |
| Milk derived hydrolysate | Active comparator | Not described Receives: Dietary Supplement: Milk derived hydrolysate; Other: Lipid Load |
| Parent Protein | Active comparator | Not described Receives: Dietary Supplement: Parent Protein; Other: Lipid Load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Disposal Rate
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
Measured: 12 weeks
Secondary outcomes (6)
Markers of glycaemic control
Glucose (mmol/L)
Measured: 12 weeks
Markers of glycaemic control
Insulin (mU/L)inflammatory markers
Measured: 12 weeks
Lipid Profile
Non-esterified fatty acids (mmol/L)
Measured: 12 weeks
Lipid Profile
Triglycerides (mmol/L) and other related lipid markers
Measured: 12 weeks
Inflammatory Markers
High sensitivity C reactive protein (mg/L)
Measured: 12 weeks
Inflammatory Markers
C-peptide (ng/mL) and other related
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study startOct 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Enterprise Ireland
- Responsible party
- Principal investigator, Prof Helen M Roche, University College Dublin
- Investigators
- Helen M Roche, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102463
- Sponsor's protocol ID
- FHI-3
- Status last verified
- Aug 2017
- First submitted
- 26 Feb 2016
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Milk Derived Peptides on Glycaemic Control
- ClinicalTrials.gov ID
- NCT03102463
- Acronym / sponsor ID
- FHI-3
- Conditions
- Insulin Resistance
- Keywords
- Insulin sensitivity, Obesity, Insulin resistance, Milk derived hydrolysate, Hyperinsulinemic-euglycaemic clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Enterprise Ireland
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
This study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. A comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve insulin resistance in cell and animal models. Therefore the investigators aim is to test their efficacy in overweight, insulin resistant individuals at risk of developing type 2 diabetes.
Detailed description
Recent figures estimate 60% of Irish adults are overweight or obese. As obesity is associated with the development of insulin resistance, which precedes type 2 diabetes development by decades, novel food based solutions are required to improve glycaemic control and attenuate insulin resistance.
In the current study insulin resistant individuals will undergo 4 study visits, 1 screening visit and 3 subsequent visits. At each of the 3 visits they will receive an oral lipid load consisting of 100mL soya bean oil, followed by either a water control; the hydrolysate being tested or the parent protein from which the hydrolysate was derived. After which they will undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water Control | Sham comparator | Dietary Supplement: Water Control, Other: Lipid Load |
| Milk derived hydrolysate | Active comparator | Dietary Supplement: Milk derived hydrolysate, Other: Lipid Load |
| Parent Protein | Active comparator | Dietary Supplement: Parent Protein, Other: Lipid Load |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - 65 years
- BMI > 26 kg/m2
- Prepared to maintain a constant body weight for the duration of the study
- Free of any chronic or infectious disease
- Not taking any medication for the regulation of blood sugars
Key exclusion criteria (6 listed)
- <18 or >65 years
- Diabetes (pharmacologically treated) or other endocrine disorders.
- Chronic inflammatory conditions.
- Kidney or liver dysfunction.
- Anaemia (Haemoglobin <12g/dl men, < 11g/dl women).
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 |
|---|---|---|
| Water Control120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp | Dietary supplement | Water Control |
| Milk derived hydrolysateMilk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp | Dietary supplement | Milk derived hydrolysate |
| Parent ProteinParent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp | Dietary supplement | Parent Protein |
| Lipid Load100mL oral lipid load | Other | Milk derived hydrolysate, Parent Protein, Water Control |
Primary outcome
Glucose Disposal Rate
Time frame: 12 weeks
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
6 secondary outcomes
Markers of glycaemic control
Time frame: 12 weeks
Markers of glycaemic control
Time frame: 12 weeks
Lipid Profile
Time frame: 12 weeks
Lipid Profile
Time frame: 12 weeks
Inflammatory Markers
Time frame: 12 weeks
Inflammatory Markers
Time frame: 12 weeks
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 14 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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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.
Helen M Roche, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk derived hydrolysate, Parent Protein and Lipid Load in people with Insulin Resistance, run by University College Dublin at 1 site in Ireland.
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 8 inclusion and 6 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 14 Aug 2017. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Glucose Disposal Rate (time frame: 12 weeks). 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 14 Aug 2017.