- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02651051
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast
The Influence of Whey Protein Addition to a Fat-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Faculty of Health and Life Sciences, Northumbria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Director: Emma J Stevenson, PhD, Northumbria University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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