NCT02651051

Brief Summary

The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in fat content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 7, 2016

Last Update Submit

January 7, 2016

Conditions

Healthy

Keywords

Postprandial glycemiaMetabolic health measures

Outcome Measures

Primary Outcomes (1)

  • Postprandial blood glucose responses

    Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch

    0-360 minutes post breakfast

Secondary Outcomes (1)

  • Acute subjective appetite responses

    0-360 minutes post breakfast

Study Arms (2)

High Fat Breakfast Meal

SHAM COMPARATOR

High fat breakfast meal served without addition of whey protein isolate

Other: High Fat Breakfast Meal

High Fat Breakfast Meal + Whey Protein

EXPERIMENTAL

High fat breakfast meal served with addition of whey protein isolate

Dietary Supplement: Whey ProteinOther: High Fat Breakfast Meal

Interventions

Whey ProteinDIETARY_SUPPLEMENT

20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal

High Fat Breakfast Meal + Whey Protein
High Fat Breakfast MealOTHER

A standardised high fat breakfast served to all participants. The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total)

High Fat Breakfast MealHigh Fat Breakfast Meal + Whey Protein

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-40 years old (male)
  • Recreationally active (\>30 minutes of structured exercise, 5 times/week)

You may not qualify if:

  • Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)
  • Taking any prescribed medication
  • Regular breakfast skipper
  • Food allergies or intolerances
  • Eating disorders
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health and Life Sciences, Northumbria University

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

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Emma J Stevenson, PhD

    Northumbria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

GB(1)