Cardiovascular DiseaseCAROTFoodsNCT02246985
Bioavailability of Carotenoids Added Into Processed Foods
A study testing Vegetable bread only, Plain bread with vegetable mayonnaise and Vegetable bread with plain mayonnaise in people with Cardiovascular Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for the human body as precursors of vitamin A. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Vegetable bread only, Plain bread with vegetable mayonnaise and Vegetable bread with plain mayonnaise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Jul 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females Aged between 18 and 75 years. Body mass index between 18.5 - 40 kg/m2. Blood pressure equal to or less than 139/89 mmHG. HbA1C less than or equal to 6.5%. Total blood cholesterol less than 6.0mmol/l
Who cannot join
- Suffering from Diabetes, kidney disease, hepatic disease, gout, gastrointestinal disorder, thromboembolic or coagulation disease, hypertension, thyroid disorder or hypercholesterolaemia On prescription medications Orlistat, Digoxin, Anti-arrhythmics, tricyclic anti-depressants, neuroleptics, oral anti-diabetic medication, insulin, anti-inflammatories, anti-pyretics and Statins Allergic/Intolerant to any of the foods in the study Vegetarian or Vegan Restricted eating and/or eating disorders Alcohol and/or substance abuse Regularly take nutritional supplements (once a day) Smoking Poor venous access and veins difficult to cannulate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, Human Nutrition Unit
Aberdeen, AB21 9SB
About this study
Official title: Bioavailability of Carotenoids Incorporated Into Processed Foods: Bread and Mayonnaise
Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for the human body as precursors of vitamin A. They are also thought to be important as anti-oxidants and may help protect against cancer and heart disease. Although many foods are rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed and available for metabolism in humans.
Devising practical ways and means of increasing carotenoid bioavailability could lead to better health outcomes. Processed foods are now widely eaten by many, both for their taste and convenience. No studies have thus far looked at the bioavailability of carotenoids that have been added into processed foods. Thus the purpose of this study is to investigate the bioavailability of carotenoids that have been incorporated into processed food products (bread and mayonnaise).
Read the detailed description
Carotenoids are a diverse group of natural-occurring fat-soluble pigments. Whilst over 600 different types have been characterised around 20 have been found in human tissue in the postprandial state, however, over 90% of these absorbed carotenoids are made up of 6 specific types (alpha-Carotene, beta-carotene, Lycopene, Lutein, Zeaxanthin and Cryptoxanthin)
There is good evidence to suggest that carotenoids play a notable role in human health both through their pro-vitamin activity and as biological antioxidants. Carotenoids are believed to be responsible for the beneficial effects of fruits and vegetables in preventing human chronic diseases such as cancer and cardiovascular disease. Increasing fruit and vegetables intakes in individuals can sometimes be difficult and unsustainable, therefore, increasing bioavailability may be an effective alternative approach to maximise health outcomes.
A notable number of vegetables are rich sources of carotenoids, however, the amounts available to the human body for metabolism are often small due to poor bioavailability. For instance, studies have shown that bioavailability of carotenoids from carrots and tomatoes can be as low as 1-3%. The bioavailability of carotenoids has been shown to depend on factors such as their source, degree of cooking, processing, mechanical breakdown, presence of fat and interactions between carotenoids. Whilst the presence of fat significantly increases carotenoid absorption, the oil type, quantity and form it is in all affect bioavailability.
Recent work suggests that carotenoid bioavailability improves when fat is present in the form of mayonnaise rather than as plain oil. This may be due to the emulsion properties of mayonnaise which allows better solubilisation of amphiphilic compounds such as carotenoids. Mayonnaise has also been shown to be more miscible in gastric juices (compared to plain oil) and this too may be contributing to the greater absorption of carotenoids.
The present study builds upon this previous work and studies carotenoid bioavailability in processed food systems. Using a bread-mayonnaise meal the study compares carotenoid bioavailability when it is incorporated either into the bread or the mayonnaise. Furthermore, the study investigates the impact of mayonnaise on the bioavailability of carotenoids incorporated into a processed food (bread). The study will focus on the bioavailability of three principle carotenoids found in foods, alpha-carotene, beta-carotene and lycopene. Carrot and tomato are used as the sources of carotenoids.
HYPOTHESIS Carotenoid bioavailability is influenced by the food matrix in which they are contained.
OBJECTIVES
- To compare the acute-phase bioavailability (systemic and gut absorption) of targeted carotenoids (alpha-carotene, beta-carotene and lycopene) when they are incorporated into the different processed food matrices (bread and mayonnaise)
- Study how mayonnaise affects the acute bioavailability of carotenoids incorporated into a processed food.
- Conditions
- Cardiovascular Disease
- Being tested
- Control, Vegetable bread only, Plain bread with vegetable mayonnaise, Vegetable bread with plain mayonnaise
- Keywords
- Processed foods, Carotenoids in plasma, urine and faeces, alpha-carotene, beta-carotene, Vitamin A, Lycopene, Gut absorption, Bread, Mayonnaise, Bioavailability, Fruits and Vegetables, Inflammation, Oxidative Stress
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Also called plain bread with plain mayonnaise
The bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids.
Vegetable bread onlyDietary supplement
A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids.
Plain bread with vegetable mayonnaiseDietary supplement
Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.
Vegetable bread with plain mayonnaiseDietary supplement
A vegetable powder (Carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids
| Study group | Role | What they receive |
|---|---|---|
| Plain bread with plain mayonnaise | Experimental | Control meal. The bread and mayonnaise in this meal does not have vegetable powders incorporated into them, hence this meal does not contain carotenoids Receives: Dietary Supplement: Control |
| Vegetable bread only | Experimental | A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids Receives: Dietary Supplement: Vegetable bread only |
| Vegetable bread with plain mayonnaise | Experimental | A vegetable powder (carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids. Receives: Dietary Supplement: Vegetable bread with plain mayonnaise |
| Plain bread with vegetable mayonnaise | Experimental | Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids. Receives: Dietary Supplement: Plain bread with vegetable mayonnaise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction
Carotenoids in plasma and in the chylomicron-rich fraction will be measured using reverse-phase HPLC
Measured: At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal
Secondary outcomes (1)
Change in carotenoid concentration in urine
Carotenoids in urine will be measured using reverse-phase HPLC
Measured: at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viren Ranawana, Msc, PhD, Principal investigator, Rowett Institute of Nutrition & Health, University of Aberdeen, Greenburn Road, Bucksburn, Aberdeen,, United Kingdom AB21 9SB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246985
- Sponsor's protocol ID
- 14/HSMC/2010
- Acronym
- CAROTFoods
- Status last verified
- Mar 2016
- First submitted
- 18 Sep 2014
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Carotenoids Incorporated Into Processed Foods: Bread and Mayonnaise
- ClinicalTrials.gov ID
- NCT02246985
- Acronym / sponsor ID
- CAROTFoods / 14/HSMC/2010
- Conditions
- Cardiovascular Disease
- Keywords
- Processed foods, Carotenoids in plasma, urine and faeces, alpha-carotene, beta-carotene, Vitamin A, Lycopene, Gut absorption, Bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Sep 2014 (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.
Carotenoids are a family of pigments found abundantly in fruits and vegetables. They are responsible for the colour of many fruits and vegetables such as tomatoes, melon, peppers and orange coloured fruits and vegetables. Carotenoids such as beta-carotene are important for the human body as precursors of vitamin A. They are also thought to be important as anti-oxidants and may help protect against cancer and heart disease. Although many foods are rich sources of carotenoids poor bioavailability often limits the amounts that are absorbed and available for metabolism in humans.
Devising practical ways and means of increasing carotenoid bioavailability could lead to better health outcomes. Processed foods are now widely eaten by many, both for their taste and convenience. No studies have thus far looked at the bioavailability of carotenoids that have been added into processed foods. Thus the purpose of this study is to investigate the bioavailability of carotenoids that have been incorporated into processed food products (bread and mayonnaise).
Detailed description
Carotenoids are a diverse group of natural-occurring fat-soluble pigments. Whilst over 600 different types have been characterised around 20 have been found in human tissue in the postprandial state, however, over 90% of these absorbed carotenoids are made up of 6 specific types (alpha-Carotene, beta-carotene, Lycopene, Lutein, Zeaxanthin and Cryptoxanthin)
There is good evidence to suggest that carotenoids play a notable role in human health both through their pro-vitamin activity and as biological antioxidants. Carotenoids are believed to be responsible for the beneficial effects of fruits and vegetables in preventing human chronic diseases such as cancer and cardiovascular disease. Increasing fruit and vegetables intakes in individuals can sometimes be difficult and unsustainable, therefore, increasing bioavailability may be an effective alternative approach to maximise health outcomes.
A notable number of vegetables are rich sources of carotenoids, however, the amounts available to the human body for metabolism are often small due to poor bioavailability. For instance, studies have shown that bioavailability of carotenoids from carrots and tomatoes can be as low as 1-3%. The bioavailability of carotenoids has been shown to depend on factors such as their source, degree of cooking, processing, mechanical breakdown, presence of fat and interactions between carotenoids. Whilst the presence of fat significantly increases carotenoid absorption, the oil type, quantity and form it is in all affect bioavailability.
Recent work suggests that carotenoid bioavailability improves when fat is present in the form of mayonnaise rather than as plain oil. This may be due to the emulsion properties of mayonnaise which allows better solubilisation of amphiphilic compounds such as carotenoids. Mayonnaise has also been shown to be more miscible in gastric juices (compared to plain oil) and this too may be contributing to the greater absorption of carotenoids.
The present study builds upon this previous work and studies carotenoid bioavailability in processed food systems. Using a bread-mayonnaise meal the study compares carotenoid bioavailability when it is incorporated either into the bread or the mayonnaise. Furthermore, the study investigates the impact of mayonnaise on the bioavailability of carotenoids incorporated into a processed food (bread). The study will focus on the bioavailability of three principle carotenoids found in foods, alpha-carotene, beta-carotene and lycopene. Carrot and tomato are used as the sources of carotenoids.
HYPOTHESIS Carotenoid bioavailability is influenced by the food matrix in which they are contained.
OBJECTIVES
- To compare the acute-phase bioavailability (systemic and gut absorption) of targeted carotenoids (alpha-carotene, beta-carotene and lycopene) when they are incorporated into the different processed food matrices (bread and mayonnaise)
- Study how mayonnaise affects the acute bioavailability of carotenoids incorporated into a processed food.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plain bread with plain mayonnaise | Experimental | Dietary Supplement: ControlControl meal. The bread and mayonnaise in this meal does not have vegetable powders incorporated into them, hence this meal does not contain carotenoids |
| Vegetable bread only | Experimental | Dietary Supplement: Vegetable bread onlyA vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids |
| Vegetable bread with plain mayonnaise | Experimental | Dietary Supplement: Vegetable bread with plain mayonnaiseA vegetable powder (carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread will be standardised to contain a known amount of carotenoids. |
| Plain bread with vegetable mayonnaise | Experimental | Dietary Supplement: Plain bread with vegetable mayonnaisePlain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males and females Aged between 18 and 75 years. Body mass index between 18.5 - 40 kg/m2. Blood pressure equal to or less than 139/89 mmHG. HbA1C less than or equal to 6.5%. Total blood cholesterol less than 6.0mmol/l
Key exclusion criteria (1 listed)
- Suffering from Diabetes, kidney disease, hepatic disease, gout, gastrointestinal disorder, thromboembolic or coagulation disease, hypertension, thyroid disorder or hypercholesterolaemia On prescription medications Orlistat, Digoxin, Anti-arrhythmics, tricyclic anti-depressants, neuroleptics, oral anti-diabetic medication, insulin, anti-inflammatories, anti-pyretics and Statins Allergic/Intolerant to any of the foods in the study Vegetarian or Vegan Restricted eating and/or eating disorders Alcohol and/or substance abuse Regularly take nutritional supplements (once a day) Smoking Poor venous access and veins difficult to cannulate
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 |
|---|---|---|
| ControlAlso: plain bread with plain mayonnaiseThe bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids. | Dietary supplement | Plain bread with plain mayonnaise |
| Vegetable bread onlyA vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids. | Dietary supplement | Vegetable bread only |
| Plain bread with vegetable mayonnaisePlain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids. | Dietary supplement | Plain bread with vegetable mayonnaise |
| Vegetable bread with plain mayonnaiseA vegetable powder (Carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids | Dietary supplement | Vegetable bread with plain mayonnaise |
Primary outcome
Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction
Time frame: At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal
Carotenoids in plasma and in the chylomicron-rich fraction will be measured using reverse-phase HPLC
1 secondary outcome
Change in carotenoid concentration in urine
Time frame: at baseline and at every hour for up to 8 hours post-prandial and at 24hours after test meal
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 27 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Viren Ranawana, Msc, PhD principal investigator
Rowett Institute of Nutrition & Health, University of Aberdeen, Greenburn Road, Bucksburn, Aberdeen,, United Kingdom AB21 9SB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetable bread only, Plain bread with vegetable mayonnaise and Vegetable bread with plain mayonnaise in people with Cardiovascular Disease, run by University of Aberdeen 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 1 inclusion and 1 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 27 Feb 2017. 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. 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?
Change in Carotenoid concentrations in plasma and in chylomicron-rich fraction (time frame: At baseline, at every hour for up to 8 hours postprandial and at 24hours after test meal). 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 27 Feb 2017.