Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast

January 7, 2016 updated by: Northumbria University

The Influence of Whey Protein Addition to a Fat-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Participants will be asked to report to the lab for their first main trial, having not eaten for 12 hours, and refrained from caffeine and alcohol intake and strenuous exercise for 24 hours. Both trials will take place at the same time of day.

Upon arrival height and body mass will be recorded and a cannula will be inserted into a vein in the back of the hand and a 10 ml blood sample will be taken.A visual analogue scale (VAS) will then be used to subjectively measure the participant's appetite pre-breakfast.

Participants will then be provided with one of the two breakfast meals that are being tested in a randomised order. The two breakfasts consist of a high fat breakfast or high fat plus additional whey protein. A drink of water shall also be consumed, the volume of which depends on the trial being carried out. The high fat breakfast will consist of scrambled egg yolks made with single cream and butter (Tesco, Hertfordshire, UK). The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total). For the whey protein trial, 23.9g whey protein isolate (Lacprodan DI-9224, Arla Foods, Denmark) shall be added to water and incorporated into each meal as a drink on the side, in order to provide 20g whey protein.

A timer shall be set when the participant takes their first mouthful of breakfast, and they will be required to rest for the following 3 hours. At 15, 30, 45, 60, 90, 120, 150 and 180 minutes post-breakfast 10 ml blood samples shall be collected. Every 30 minutes during this period the appetite VAS will also be completed. After this participants will be provided with a standardised lunch meal which shall consist of pasta with a tomato and basil sauce, olive oil and cheddar cheese, along with a 350 ml drink of water. The macronutrient distribution of the lunch is 13% protein, 49% carbohydrate, 38% fat. Following this, the post-breakfast procedure shall be repeated for another period of 3 hours.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
        • Faculty of Health and Life Sciences, Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: High Fat Breakfast Meal
High fat breakfast meal served without addition of whey protein isolate
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)
Experimental: High Fat Breakfast Meal + Whey Protein
High fat breakfast meal served with addition of whey protein isolate
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)
20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial blood glucose responses
Time Frame: 0-360 minutes post breakfast
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch
0-360 minutes post breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute subjective appetite responses
Time Frame: 0-360 minutes post breakfast
Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals
0-360 minutes post breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Emma J Stevenson, PhD, Northumbria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • HLS-13-131017b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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