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Whey Protein Effect on Glycaemic and Appetite Responses in T2D

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ClinicalTrials.gov Identifier: NCT02903199
Recruitment Status : Unknown
Verified August 2016 by Northumbria University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Northumbria University

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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Dietary Supplement: Whey Protein Dietary Supplement: Hydrolysed Protein Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males
Study Start Date : July 2015
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Whey Protein
Whey protein (18g) experimental supplement
Dietary Supplement: Whey Protein
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.

Experimental: Hydrolysed Protein
Hydrolysed whey protein (19.1g) experimental supplement
Dietary Supplement: Hydrolysed Protein
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.

Placebo Comparator: Placebo
Water placebo supplement
Dietary Supplement: Placebo
Placebo intervention administered immediately prior to breakfast and lunch meals.




Primary Outcome Measures :
  1. Postprandial capillary glucose [ Time Frame: 6 hours per week, for 3 weeks. ]
    Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).


Secondary Outcome Measures :
  1. Plasma Glucagon-like Peptide-1 (GLP-1) [ Time Frame: 3 weeks ]
    GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.

  2. Plasma Gastric Inhibitory Polypeptide (GIP) [ Time Frame: 3 weeks ]
    GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.

  3. Plasma Leptin [ Time Frame: 3 weeks ]
    Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.

  4. Plasma Peptide YY (PYY3-36) [ Time Frame: 3 weeks ]
    PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.

  5. Plasma Insulin [ Time Frame: 3 weeks ]
    Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.

  6. Serum Triglycerides [ Time Frame: 3 weeks ]
    Triglycerides will be measured from Serum Separating Tubes (SST).

  7. Serum Glycerol [ Time Frame: 3 weeks ]
    Glycerol will be measured from Serum Separating Tubes (SST).

  8. Self-Report Questionnaire for Appetite [ Time Frame: 3 weeks ]
    Visual Analogue Scales (VAS) will be used to assess self reported feelings of appetite sensations (i.e. hunger, satiety, prospective food intake).

  9. 24 h Interstitial Glucose [ Time Frame: 3 days per week, for 3 weeks ]
    Interstitial glucose is measured from 36 h prior to the trial, until 24 h following the trial, each week for three weeks.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903199


Locations
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United Kingdom
Northumbria University
Newcastle-upon-Tyne, Tyne & Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
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Principal Investigator: Mark Walker Newcastle University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT02903199     History of Changes
Other Study ID Numbers: NorthumbriaT2D
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Northumbria University:
Whey Protein
Postprandial Glycaemia
Appetite Response

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases