Modified Whey Protein and Effect on Post Meal Glucose Levels Study (MWPS)
Primary Purpose
Metabolism Disorder, Glucose
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control
Normal Whey protein
Modified whey protein
Sponsored by
About this trial
This is an interventional prevention trial for Metabolism Disorder, Glucose focused on measuring Whey protein, Dietary supplementation, Glucose, GLP-1, Satiety
Eligibility Criteria
Inclusion Criteria:
- Healthy men and women aged 55-75years
- Body Mass index range from 25-35 kg/m2
- Blood pressure below 160/90mmHg
Exclusion Criteria:
- 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
Sites / Locations
- University of Aberdeen, The Rowett Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control
Normal Whey protein
Modified Whey
Arm Description
No Whey Protein
Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
Modified whey protein will be given
Outcomes
Primary Outcome Measures
Insulin response
Post supplementation levels of glucose will be measured to assess insulin response
Secondary Outcome Measures
Insulin Concentration
Post supplementation levels of Insulin will be measured to assess insulin response
GLP-1 level
Post supplementation levels of GLP-1 will be measured to assess insulin response
C-peptide levels
Post supplementation levels of C-peptide will be measured to assess insulin response
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
Full Information
NCT ID
NCT03056677
First Posted
February 7, 2017
Last Updated
December 11, 2018
Sponsor
University of Aberdeen
1. Study Identification
Unique Protocol Identification Number
NCT03056677
Brief Title
Modified Whey Protein and Effect on Post Meal Glucose Levels Study
Acronym
MWPS
Official Title
Does Modified Whey Protein Lower Post Meal Glucose Levels
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder, Glucose
Keywords
Whey protein, Dietary supplementation, Glucose, GLP-1, Satiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
No Whey Protein
Arm Title
Normal Whey protein
Arm Type
Experimental
Arm Description
Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
Arm Title
Modified Whey
Arm Type
Experimental
Arm Description
Modified whey protein will be given
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
200mls water will be given prior to a mixed carbohydrate meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal Whey protein
Intervention Description
Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified whey protein
Intervention Description
Modified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
Primary Outcome Measure Information:
Title
Insulin response
Description
Post supplementation levels of glucose will be measured to assess insulin response
Time Frame
18months
Secondary Outcome Measure Information:
Title
Insulin Concentration
Description
Post supplementation levels of Insulin will be measured to assess insulin response
Time Frame
18 months
Title
GLP-1 level
Description
Post supplementation levels of GLP-1 will be measured to assess insulin response
Time Frame
18months
Title
C-peptide levels
Description
Post supplementation levels of C-peptide will be measured to assess insulin response
Time Frame
18months
Title
Increased satiety using a visual analogue scale
Description
At baseline and 3 hours post consumption satiety will be measured by completion of a visual analogue scale questionnaire
Time Frame
5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men and women aged 55-75years
Body Mass index range from 25-35 kg/m2
Blood pressure below 160/90mmHg
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda Williams, BSc, PhD
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aberdeen, The Rowett Institute
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Modified Whey Protein and Effect on Post Meal Glucose Levels Study
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