Modified Whey Protein and Effect on Post Meal Glucose Levels Study

NCT ID: NCT03056677

Last Updated: 2018-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Metabolism Disorder, Glucose

Keywords

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Whey protein Dietary supplementation Glucose GLP-1 Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

No Whey Protein

Group Type EXPERIMENTAL

Control

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Normal Whey protein

Intervention Type DIETARY_SUPPLEMENT

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

Modified Whey

Modified whey protein will be given

Group Type EXPERIMENTAL

Modified whey protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Control

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

Intervention Type DIETARY_SUPPLEMENT

Normal Whey protein

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

Intervention Type DIETARY_SUPPLEMENT

Modified whey protein

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynda Williams, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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University of Aberdeen, The Rowett Institute

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2016/RINH/1

Identifier Type: -

Identifier Source: org_study_id