Whey Protein Effect on Glycaemic and Appetite Responses in T2D

NCT ID: NCT02903199

Last Updated: 2016-09-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Type II Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Whey Protein

Whey protein (18g) experimental supplement

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

Whey protein (18 g) administered immediately prior to breakfast and lunch meals.

Hydrolysed Protein

Hydrolysed whey protein (19.1g) experimental supplement

Group Type EXPERIMENTAL

Hydrolysed Protein

Intervention Type DIETARY_SUPPLEMENT

Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.

Placebo

Water placebo supplement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo intervention administered immediately prior to breakfast and lunch meals.

Interventions

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Whey Protein

Whey protein (18 g) administered immediately prior to breakfast and lunch meals.

Intervention Type DIETARY_SUPPLEMENT

Hydrolysed Protein

Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo intervention administered immediately prior to breakfast and lunch meals.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Walker

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

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Northumbria University

Newcastle upon Tyne, Tyne & Wear, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 29635505 (View on PubMed)

Other Identifiers

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NorthumbriaT2D

Identifier Type: -

Identifier Source: org_study_id

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