HealthyNCT02651051
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast
A study testing Whey Protein and High Fat 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 fat 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 and High Fat 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 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Whey Protein, High Fat 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 ProteinDietary supplement
20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal
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)
| Study group | Role | What they receive |
|---|---|---|
| High Fat Breakfast Meal | Sham comparator | High fat breakfast meal served without addition of whey protein isolate Receives: Other: High Fat Breakfast Meal |
| High Fat Breakfast Meal + Whey Protein | Experimental | High fat breakfast meal served with addition of whey protein isolate Receives: Dietary Supplement: Whey Protein; Other: High Fat Breakfast Meal |
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 posted8 Jan 2016 (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
- NCT02651051
- Sponsor's protocol ID
- HLS-13-131017b
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Whey Protein Addition to a Fat-based Breakfast on Metabolic and Appetite Parameters Following a Second Meal
- ClinicalTrials.gov ID
- NCT02651051
- Acronym / sponsor ID
- HLS-13-131017b
- 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
- 8 Jan 2016 (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 fat content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fat Breakfast Meal | Sham comparator | Other: High Fat Breakfast MealHigh fat breakfast meal served without addition of whey protein isolate |
| High Fat Breakfast Meal + Whey Protein | Experimental | Dietary Supplement: Whey Protein, Other: High Fat Breakfast MealHigh fat breakfast meal served with addition of whey protein isolate |
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 Protein20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal | Dietary supplement | High Fat Breakfast Meal + Whey Protein |
| High Fat Breakfast MealA 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) | Other | High Fat Breakfast Meal, High Fat Breakfast Meal + 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 8 Jan 2016.
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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 and High Fat 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 8 Jan 2016. 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 8 Jan 2016.