- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414061
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast
April 10, 2015 updated by: Northumbria University
The Influence of Whey Protein Addition to a Carbohydrate-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 carbohydrate content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 |
---|---|
Experimental: Breakfast - Carbohydrate + Whey Protein
Addition of whey protein isolate (20 g dissolved in flavoured water) to breakfast meal composition
|
20 g whey protein isolate added to breakfast meal
Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)
|
Placebo Comparator: Breakfast - Carbohydrate
Only flavoured water consumed with breakfast meal
|
Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)
|
No Intervention: No Breakfast
Only water consumed at breakfast time point
|
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.
Sponsor
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
April 7, 2015
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Estimate)
April 13, 2015
Last Update Submitted That Met QC Criteria
April 10, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- HLS-13-131017
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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