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NCT Number: NCT03056677

Modified Whey Protein and Effect on Post Meal Glucose Levels Study

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.

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Key information

Conditions

Metabolism Disorder, Glucose Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

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

Normal Whey protein

Dietary Supplement

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

Modified whey protein

Dietary Supplement

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

Primary outcomes

  1. Insulin response

    Time frame: 18months

    Post supplementation levels of glucose will be measured to assess insulin response

Secondary outcomes

  1. Insulin Concentration

    Time frame: 18 months

    Post supplementation levels of Insulin will be measured to assess insulin response

  2. GLP-1 level

    Time frame: 18months

    Post supplementation levels of GLP-1 will be measured to assess insulin response

  3. C-peptide levels

    Time frame: 18months

    Post supplementation levels of C-peptide will be measured to assess insulin response

  4. Increased satiety using a visual analogue scale

    Time frame: 5 hours

    At baseline and 3 hours post consumption satiety will be measured by completion of a visual analogue scale questionnaire

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

Does Modified Whey Protein Lower Post Meal Glucose Levels

Acronym: MWPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2017
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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