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

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.

Study Overview

• Status: Completed
• Conditions: Metabolism Disorder, Glucose
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Normal Whey protein; Dietary supplement: Modified whey protein

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • University of Aberdeen, The Rowett Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin response	Post supplementation levels of glucose will be measured to assess insulin response	18months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Concentration	Post supplementation levels of Insulin will be measured to assess insulin response	18 months
GLP-1 level	Post supplementation levels of GLP-1 will be measured to assess insulin response	18months
C-peptide levels	Post supplementation levels of C-peptide will be measured to assess insulin response	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	5 hours

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Investigators: Principal Investigator: Lynda Williams, BSc, PhD, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: GLP-1; Satiety; Glucose; Whey protein; Dietary supplementation
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 2016/RINH/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No