MWPS: Modified Whey Protein and Effect on Post Meal Glucose Levels Study

Sponsor

University of Aberdeen (Other)

Overall Status

Completed

CT.gov ID

NCT03056677

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Disorder, Glucose	Dietary Supplement: Control Dietary Supplement: Normal Whey protein Dietary Supplement: Modified whey protein	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Does Modified Whey Protein Lower Post Meal Glucose Levels

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control No Whey Protein	Dietary Supplement: Control 200mls water will be given prior to a mixed carbohydrate meal
Experimental: Normal Whey protein Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal	Dietary Supplement: Normal Whey protein Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
Experimental: Modified Whey Modified whey protein will be given	Dietary Supplement: Modified whey protein Modified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal

Arm

Intervention/Treatment

Experimental: Control

No Whey Protein

Dietary Supplement: Control

200mls water will be given prior to a mixed carbohydrate meal

Experimental: Normal Whey protein

Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal

Dietary Supplement: Normal Whey protein

Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal

Experimental: Modified Whey

Modified whey protein will be given

Dietary Supplement: Modified whey protein

Modified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal

Outcome Measures

Primary Outcome Measures

Insulin response [18months]
Post supplementation levels of glucose will be measured to assess insulin response

Secondary Outcome Measures

Insulin Concentration [18 months]
Post supplementation levels of Insulin will be measured to assess insulin response
GLP-1 level [18months]
Post supplementation levels of GLP-1 will be measured to assess insulin response
C-peptide levels [18months]
Post supplementation levels of C-peptide will be measured to assess insulin response
Increased satiety using a visual analogue scale [5 hours]
At baseline and 3 hours post consumption satiety will be measured by completion of a visual analogue scale questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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