HealthyNCT02414061
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast
A study testing Whey Protein (Arla Foods Ingredients Group) and Breakfast meal in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Whey Protein (Arla Foods Ingredients Group) and Breakfast meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-40 years old (male)
- Recreationally active (>30 minutes of structured exercise, 5 times/week)
Who cannot join
- Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)
- Taking any prescribed medication
- Regular breakfast skipper
- Food allergies or intolerances
- Eating disorders
- Smoker
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Health and Life Sciences, Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Whey Protein (Arla Foods Ingredients Group), Breakfast meal
- Keywords
- Postprandial glycemia, metabolic health measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein (Arla Foods Ingredients Group)Dietary supplement
20 g whey protein isolate added to breakfast meal
Breakfast mealOther
Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)
| Study group | Role | What they receive |
|---|---|---|
| Breakfast - Carbohydrate + Whey Protein | Experimental | Addition of whey protein isolate (20 g dissolved in flavoured water) to breakfast meal composition Receives: Dietary Supplement: Whey Protein (Arla Foods Ingredients Group); Other: Breakfast meal |
| Breakfast - Carbohydrate | Placebo comparator | Only flavoured water consumed with breakfast meal Receives: Other: Breakfast meal |
| No Breakfast | No intervention | Only water consumed at breakfast time point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose responses
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch
Measured: 0-360 minutes post breakfast
Secondary outcomes (1)
Acute subjective appetite responses
Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals
Measured: 0-360 minutes post breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma J Stevenson, PhD, Study director, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414061
- Sponsor's protocol ID
- HLS-13-131017
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2015
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Whey Protein Addition to a Carbohydrate-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal
- ClinicalTrials.gov ID
- NCT02414061
- Acronym / sponsor ID
- HLS-13-131017
- Conditions
- Healthy
- Keywords
- Postprandial glycemia, metabolic health measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breakfast - Carbohydrate + Whey Protein | Experimental | Dietary Supplement: Whey Protein (Arla Foods Ingredients Group), Other: Breakfast mealAddition of whey protein isolate (20 g dissolved in flavoured water) to breakfast meal composition |
| Breakfast - Carbohydrate | Placebo comparator | Other: Breakfast mealOnly flavoured water consumed with breakfast meal |
| No Breakfast | No intervention | –Only water consumed at breakfast time point |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-40 years old (male)
- Recreationally active (>30 minutes of structured exercise, 5 times/week)
Key exclusion criteria (6 listed)
- Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)
- Taking any prescribed medication
- Regular breakfast skipper
- Food allergies or intolerances
- Eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein (Arla Foods Ingredients Group)20 g whey protein isolate added to breakfast meal | Dietary supplement | Breakfast - Carbohydrate + Whey Protein |
| Breakfast mealCarbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein) | Other | Breakfast - Carbohydrate, Breakfast - Carbohydrate + Whey Protein |
Primary outcome
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
1 secondary outcome
Acute subjective appetite responses
Time frame: 0-360 minutes post breakfast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma J Stevenson, PhD study director
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein (Arla Foods Ingredients Group) and Breakfast meal in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial blood glucose responses (time frame: 0-360 minutes post breakfast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.