Metabolism Disorder, GlucoseMWPSNCT03056677
Modified Whey Protein and Effect on Post Meal Glucose Levels Study
A study testing Normal Whey protein and Modified whey protein in people with Metabolism Disorder, Glucose, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
After meals, the level of glucose rises in the circulation. In some individuals who are overweight and older, blood glucose can rise to levels which can damage tissues and cause health problems. Usually the hormone insulin, released from the pancreas, effectively lowers blood glucose. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder, Glucose
- What is being tested?
- Normal Whey protein and Modified whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Dec 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 55-75years
- Body Mass index range from 25-35 kg/m2
- Blood pressure below 160/90mmHg
Who cannot join
- Milk or milk protein allergy
- Lactose Intolerance
- Diabetes
- Smoking
- Taking anoretic drugs, steroid medications, medications known to affect gastric motility or any hypoglycaemic agents
- Unsuitable veins for venous blood sampling
- Inability to spell, read and understand the English language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen, The Rowett Institute
Aberdeen, AB25 2ZD
About this study
Official title: Does Modified Whey Protein Lower Post Meal Glucose Levels
After meals, the level of glucose rises in the circulation. In some individuals who are overweight and older, blood glucose can rise to levels which can damage tissues and cause health problems. Usually the hormone insulin, released from the pancreas, effectively lowers blood glucose. However, in overweight and older people insulin is less effective. Certain foods can lower the rise in blood glucose, particularly proteins. This works by increasing the release of a hormone from the gut called Glucagon-Like Peptide 1 (GLP-1), which in turn increases the release of insulin. A Component of milk left over after cheese making, termed Whey protein, is particularly good at releasing GLP-1. Whey protein is used as a food additive and taken as a supplement to help build muscle. Whey protein is a mixture of proteins which the investigators have modified to be more effective at lowering blood glucose. Using laboratory tests the investigators identified a protein present in Whey that does not increase levels of GLP-1 and removed it. It's removal raises the levels of other proteins which are more effective. In this study, the investigators would like to test the effectiveness of the "modified" whey protein. To do this, 30 older, overweight volunteers will be recruited and given the modified whey protein, a normal whey protein or a mixture of amino acids and then a breakfast meal to raise their blood glucose levels. These drinks will be given in a randomised sequence 1 week apart. On each visit, blood samples to measure blood glucose and related hormone levels will be taken. As GLP-1 can also have an effect on appetite, the investigators will measure the effect of the modified whey protein on subsequent appetite in the volunteers by asking them how hungry they feel.
Read the detailed description
The prevalence of obesity and associated type 2 diabetes has risen dramatically, adversely affecting health and life expectancy and increasing health care costs. There is an urgent need to lower the incidence or delay the onset of both conditions by lifestyle-related interventions. Dietary whey protein acts in the gut to release GLP-1 and insulin release, thereby lowering post-meal glucose levels and satiety. Whey protein is a mixture of proteins which the investigators have modified to be potentially more effective at lowering blood glucose. Using laboratory tests, a protein present in whey that does not increase levels of GLP-1 was identified and removed. Its removal raises the levels of other proteins which are more effective. The study will test the effectiveness of the "modified" whey protein. If the modified whey protein is found to be more effective it may be used to minimise the post-meal rise in glucose levels.
- Conditions
- Metabolism Disorder, Glucose
- Being tested
- Control, Normal Whey protein, Modified whey protein
- Keywords
- Whey protein, Dietary supplementation, Glucose, GLP-1, Satiety
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
200mls water will be given prior to a mixed carbohydrate meal
Normal Whey proteinDietary supplement
Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
Modified whey proteinDietary supplement
Modified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | No Whey Protein Receives: Dietary Supplement: Control |
| Normal Whey protein | Experimental | Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal Receives: Dietary Supplement: Normal Whey protein |
| Modified Whey | Experimental | Modified whey protein will be given Receives: Dietary Supplement: Modified whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin response
Post supplementation levels of glucose will be measured to assess insulin response
Measured: 18months
Secondary outcomes (4)
Insulin Concentration
Post supplementation levels of Insulin will be measured to assess insulin response
Measured: 18 months
GLP-1 level
Post supplementation levels of GLP-1 will be measured to assess insulin response
Measured: 18months
C-peptide levels
Post supplementation levels of C-peptide will be measured to assess insulin response
Measured: 18months
Increased satiety using a visual analogue scale
At baseline and 3 hours post consumption satiety will be measured by completion of a visual analogue scale questionnaire
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startAug 2016
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism Disorder, GlucoseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynda Williams, BSc, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056677
- Sponsor's protocol ID
- 2016/RINH/1
- Acronym
- MWPS
- Status last verified
- Dec 2018
- First submitted
- 7 Feb 2017
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Modified Whey Protein Lower Post Meal Glucose Levels
- ClinicalTrials.gov ID
- NCT03056677
- Acronym / sponsor ID
- MWPS / 2016/RINH/1
- Conditions
- Metabolism Disorder, Glucose
- Keywords
- Whey protein, Dietary supplementation, Glucose, GLP-1, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Feb 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.
After meals, the level of glucose rises in the circulation. In some individuals who are overweight and older, blood glucose can rise to levels which can damage tissues and cause health problems. Usually the hormone insulin, released from the pancreas, effectively lowers blood glucose. However, in overweight and older people insulin is less effective. Certain foods can lower the rise in blood glucose, particularly proteins. This works by increasing the release of a hormone from the gut called Glucagon-Like Peptide 1 (GLP-1), which in turn increases the release of insulin. A Component of milk left over after cheese making, termed Whey protein, is particularly good at releasing GLP-1. Whey protein is used as a food additive and taken as a supplement to help build muscle. Whey protein is a mixture of proteins which the investigators have modified to be more effective at lowering blood glucose. Using laboratory tests the investigators identified a protein present in Whey that does not increase levels of GLP-1 and removed it. It's removal raises the levels of other proteins which are more effective. In this study, the investigators would like to test the effectiveness of the "modified" whey protein. To do this, 30 older, overweight volunteers will be recruited and given the modified whey protein, a normal whey protein or a mixture of amino acids and then a breakfast meal to raise their blood glucose levels. These drinks will be given in a randomised sequence 1 week apart. On each visit, blood samples to measure blood glucose and related hormone levels will be taken. As GLP-1 can also have an effect on appetite, the investigators will measure the effect of the modified whey protein on subsequent appetite in the volunteers by asking them how hungry they feel.
Detailed description
The prevalence of obesity and associated type 2 diabetes has risen dramatically, adversely affecting health and life expectancy and increasing health care costs. There is an urgent need to lower the incidence or delay the onset of both conditions by lifestyle-related interventions. Dietary whey protein acts in the gut to release GLP-1 and insulin release, thereby lowering post-meal glucose levels and satiety. Whey protein is a mixture of proteins which the investigators have modified to be potentially more effective at lowering blood glucose. Using laboratory tests, a protein present in whey that does not increase levels of GLP-1 was identified and removed. Its removal raises the levels of other proteins which are more effective. The study will test the effectiveness of the "modified" whey protein. If the modified whey protein is found to be more effective it may be used to minimise the post-meal rise in glucose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: ControlNo Whey Protein |
| Normal Whey protein | Experimental | Dietary Supplement: Normal Whey proteinWhey protein (50grams) drink will be given prior to a mixed carbohydrate meal |
| Modified Whey | Experimental | Dietary Supplement: Modified whey proteinModified whey protein will be given |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men and women aged 55-75years
- Body Mass index range from 25-35 kg/m2
- Blood pressure below 160/90mmHg
Key exclusion criteria (7 listed)
- Milk or milk protein allergy
- Lactose Intolerance
- Diabetes
- Smoking
- Taking anoretic drugs, steroid medications, medications known to affect gastric motility or any hypoglycaemic agents
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 |
|---|---|---|
| Control200mls water will be given prior to a mixed carbohydrate meal | Dietary supplement | Control |
| Normal Whey proteinWhey protein (50grams) drink will be given prior to a mixed carbohydrate meal | Dietary supplement | Normal Whey protein |
| Modified whey proteinModified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal | Dietary supplement | Modified Whey |
Primary outcome
Insulin response
Time frame: 18months
Post supplementation levels of glucose will be measured to assess insulin response
4 secondary outcomes
Insulin Concentration
Time frame: 18 months
GLP-1 level
Time frame: 18months
C-peptide levels
Time frame: 18months
Increased satiety using a visual analogue scale
Time frame: 5 hours
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 12 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Lynda Williams, BSc, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Whey protein and Modified whey protein in people with Metabolism Disorder, Glucose, run by University of Aberdeen 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 3 inclusion and 7 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 12 Dec 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?
Insulin response (time frame: 18months). 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 12 Dec 2018.