NCT03056677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

February 7, 2017

Last Update Submit

December 11, 2018

Conditions

Metabolism Disorder, Glucose

Keywords

Whey proteinDietary supplementationGlucoseGLP-1Satiety

Outcome Measures

Primary Outcomes (1)

  • Insulin response

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

    18months

Secondary Outcomes (4)

  • Insulin Concentration

    18 months

  • GLP-1 level

    18months

  • C-peptide levels

    18months

  • Increased satiety using a visual analogue scale

    5 hours

Study Arms (3)

Control

EXPERIMENTAL

No Whey Protein

Dietary Supplement: Control

Normal Whey protein

EXPERIMENTAL

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

Dietary Supplement: Normal Whey protein

Modified Whey

EXPERIMENTAL

Modified whey protein will be given

Dietary Supplement: Modified whey protein

Interventions

ControlDIETARY_SUPPLEMENT

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

Control
Normal Whey proteinDIETARY_SUPPLEMENT

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

Normal Whey protein
Modified whey proteinDIETARY_SUPPLEMENT

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

Modified Whey

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women aged 55-75years
  • Body Mass index range from 25-35 kg/m2
  • Blood pressure below 160/90mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen, The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lynda Williams, BSc, PhD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 17, 2017

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 12, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)