NCT02903199

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 16, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

August 2, 2016

Last Update Submit

September 12, 2016

Conditions

Type II Diabetes MellitusGlucose Metabolism DisordersMetabolic Diseases

Keywords

Whey ProteinPostprandial GlycaemiaAppetite Response

Outcome Measures

Primary Outcomes (1)

  • Postprandial capillary glucose

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

    6 hours per week, for 3 weeks.

Secondary Outcomes (9)

  • Plasma Glucagon-like Peptide-1 (GLP-1)

    3 weeks

  • Plasma Gastric Inhibitory Polypeptide (GIP)

    3 weeks

  • Plasma Leptin

    3 weeks

  • Plasma Peptide YY (PYY3-36)

    3 weeks

  • Plasma Insulin

    3 weeks

  • +4 more secondary outcomes

Study Arms (3)

Whey Protein

EXPERIMENTAL

Whey protein (18g) experimental supplement

Dietary Supplement: Whey Protein

Hydrolysed Protein

EXPERIMENTAL

Hydrolysed whey protein (19.1g) experimental supplement

Dietary Supplement: Hydrolysed Protein

Placebo

PLACEBO COMPARATOR

Water placebo supplement

Dietary Supplement: Placebo

Interventions

Whey ProteinDIETARY_SUPPLEMENT

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

Whey Protein
Hydrolysed ProteinDIETARY_SUPPLEMENT

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

Hydrolysed Protein
PlaceboDIETARY_SUPPLEMENT

Placebo intervention administered immediately prior to breakfast and lunch meals.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29635505DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic Diseases

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Diabetes MellitusNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mark Walker

    Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2016

First Posted

September 16, 2016

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

October 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-08

Locations

GB(1)