Modified Whey Protein and Effect on Post Meal Glucose Levels Study

Metabolism Disorder, Glucose Clinical Trial

— MWPS  

Official title:

Does Modified Whey Protein Lower Post Meal Glucose Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056677
• Other study ID #: 2016/RINH/1
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2018
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases
• Metabolism Disorder, Glucose

Intervention

Dietary Supplement:
• Control
200mls water will be given prior to a mixed carbohydrate meal
• Normal Whey protein
Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
• Modified whey protein
Modified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal

Locations

Country	Name	City	State
United Kingdom	University of Aberdeen, The Rowett Institute	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin response	Post supplementation levels of glucose will be measured to assess insulin response	18months
Secondary	Insulin Concentration	Post supplementation levels of Insulin will be measured to assess insulin response	18 months
Secondary	GLP-1 level	Post supplementation levels of GLP-1 will be measured to assess insulin response	18months
Secondary	C-peptide levels	Post supplementation levels of C-peptide will be measured to assess insulin response	18months
Secondary	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