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Whey Protein Effect on Glycaemic and Appetite Responses in T2D

Primary Purpose

Type II Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whey Protein
Hydrolysed Protein
Placebo
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Whey Protein, Postprandial Glycaemia, Appetite Response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Type II diabetic males aged 18-65 years old.
  • Treated with metformin, or diet and lifestyle modification, only.
  • BMI < 40 kg/m2.
  • Stable physical activity pattern during the three months immediately preceding study.

Exclusion Criteria:

  • Not treated with insulin.
  • No metabolic disease other than diabetes.

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Whey Protein

Hydrolysed Protein

Placebo

Arm Description

Whey protein (18g) experimental supplement

Hydrolysed whey protein (19.1g) experimental supplement

Water placebo supplement

Outcomes

Primary Outcome Measures

Postprandial capillary glucose
Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).

Secondary Outcome Measures

Plasma Glucagon-like Peptide-1 (GLP-1)
GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Plasma Gastric Inhibitory Polypeptide (GIP)
GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Plasma Leptin
Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Plasma Peptide YY (PYY3-36)
PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Plasma Insulin
Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Serum Triglycerides
Triglycerides will be measured from Serum Separating Tubes (SST).
Serum Glycerol
Glycerol will be measured from Serum Separating Tubes (SST).
Self-Report Questionnaire for Appetite
Visual Analogue Scales (VAS) will be used to assess self reported feelings of appetite sensations (i.e. hunger, satiety, prospective food intake).
24 h Interstitial Glucose
Interstitial glucose is measured from 36 h prior to the trial, until 24 h following the trial, each week for three weeks.

Full Information

First Posted
August 2, 2016
Last Updated
September 12, 2016
Sponsor
Northumbria University
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1. Study Identification

Unique Protocol Identification Number
NCT02903199
Brief Title
Whey Protein Effect on Glycaemic and Appetite Responses in T2D
Official Title
The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses.
Detailed Description
Whey protein accounts of ~20% of whole milk protein. Ingestion of whey protein at meal times generates insulinotrophic/β-cell stimulation via amino acid absorption and the bioactive peptides generated during gastrointestinal digestion, resulting in attenuation of postprandial blood glucose. The bioactive peptides stimulate the release of incretin hormone, GLP-1, and inhibit DPP-IV activity potentially decreasing the rate of GLP-1 degradation. The current study will employ a randomised, double-blind, counter-balanced, cross-over design, whereby participants will each complete three trials; a) whey protein, b) hydrolysed protein, and c) placebo intervention. Hydrolysed protein provides amino acid content, without bioactive peptides associated with incretin release, therefore, demonstrating insulinotrophic properties, only. Many studies within the literature are limited for practical reasons, such as investigating high dosages (30-50 g) of whey protein, or high glycaemic index meal types which would be unlikely to form part of habitual dietary activity of type II diabetics. Therefore, the current study will objectively measure postprandial glycaemic and appetite responses following the ingestion of whey/hydrolysed protein, whilst ensuring ecological validity, dosages (18 g) and test meals applicable to everyday life, and true clinical utility for managing type-II diabetes by integrating interventions into the habitual lives of type-II diabetic individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
Keywords
Whey Protein, Postprandial Glycaemia, Appetite Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey Protein
Arm Type
Experimental
Arm Description
Whey protein (18g) experimental supplement
Arm Title
Hydrolysed Protein
Arm Type
Experimental
Arm Description
Hydrolysed whey protein (19.1g) experimental supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein
Intervention Description
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolysed Protein
Intervention Description
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo intervention administered immediately prior to breakfast and lunch meals.
Primary Outcome Measure Information:
Title
Postprandial capillary glucose
Description
Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).
Time Frame
6 hours per week, for 3 weeks.
Secondary Outcome Measure Information:
Title
Plasma Glucagon-like Peptide-1 (GLP-1)
Description
GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Time Frame
3 weeks
Title
Plasma Gastric Inhibitory Polypeptide (GIP)
Description
GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Time Frame
3 weeks
Title
Plasma Leptin
Description
Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Time Frame
3 weeks
Title
Plasma Peptide YY (PYY3-36)
Description
PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Time Frame
3 weeks
Title
Plasma Insulin
Description
Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Time Frame
3 weeks
Title
Serum Triglycerides
Description
Triglycerides will be measured from Serum Separating Tubes (SST).
Time Frame
3 weeks
Title
Serum Glycerol
Description
Glycerol will be measured from Serum Separating Tubes (SST).
Time Frame
3 weeks
Title
Self-Report Questionnaire for Appetite
Description
Visual Analogue Scales (VAS) will be used to assess self reported feelings of appetite sensations (i.e. hunger, satiety, prospective food intake).
Time Frame
3 weeks
Title
24 h Interstitial Glucose
Description
Interstitial glucose is measured from 36 h prior to the trial, until 24 h following the trial, each week for three weeks.
Time Frame
3 days per week, for 3 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type II diabetic males aged 18-65 years old. Treated with metformin, or diet and lifestyle modification, only. BMI < 40 kg/m2. Stable physical activity pattern during the three months immediately preceding study. Exclusion Criteria: Not treated with insulin. No metabolic disease other than diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Walker
Organizational Affiliation
Newcastle University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle-upon-Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29635505
Citation
King DG, Walker M, Campbell MD, Breen L, Stevenson EJ, West DJ. A small dose of whey protein co-ingested with mixed-macronutrient breakfast and lunch meals improves postprandial glycemia and suppresses appetite in men with type 2 diabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Apr 1;107(4):550-557. doi: 10.1093/ajcn/nqy019.
Results Reference
derived

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Whey Protein Effect on Glycaemic and Appetite Responses in T2D

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