DNA DamageNCT02696811
The Effects of Foods on Cell Damage Study
A study testing White carrots and Oat biscuits in people with DNA Damage and Inflammation, run by Newcastle University at 1 site in United Kingdom.
Trial summary
Studies have shown that certain compounds inside vegetables can reduce the risk of cancer. Carrots in particular have an association with reduced incidence of colorectal, bladder and breast cancer. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- DNA Damage, Inflammation
- What is being tested?
- White carrots and Oat biscuits
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Sep 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non -smokers
- BMI between 18.5 and 30
Who cannot join
- smoking
- taking anti-inflammatories
- taking aspirin or aspirin-like drugs
- antibiotic use in the last 3 months
- metabolic conditions or conditions affecting the metabolism or digestion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Agriculture Building, Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
About this study
Official title: Randomised 6-week, Parallel Group, Placebo Controlled Intervention Trial to Investigate the Effects of White Carrots on Inflammatory Markers and Lymphocyte DNA Damage
Studies have shown that certain compounds inside vegetables can reduce the risk of cancer. Carrots in particular have an association with reduced incidence of colorectal, bladder and breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated cells that have shown a reduction in cancer cells as well as inflammatory markers which have been associated with an increased risk of cancer. These polyacetylenes have not been well studied in the human body and it is unclear whether they are able to affect the biomarkers of health (disease) including DNA damage and inflammatory markers. The aim of this research project is to determine whether eating a portion of white carrots every day for 6 weeks can lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6 weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.
- Conditions
- DNA Damage, Inflammation
- Being tested
- White carrots, Oat biscuits
- Keywords
- cancer, inflammation, dietary intervention trial
- Medical subject headings
- Inflammation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White carrotsDietary supplement
Also called Falcarinol, falcarindiol, falcarindiol-3-acetate
White carrots contain compounds called polyacetylenes, including falcarinol, falcarindiol and falcarindiol-3-acetate.
Oat biscuitsDietary supplement
The 3 oat biscuits contain the same amount of fibre and sugar as the white carrot but without the polyacetylenes.
| Study group | Role | What they receive |
|---|---|---|
| Oat biscuits | Placebo comparator | Participants will eat 3 oat biscuits per day for 6 weeks Receives: Dietary Supplement: Oat biscuits |
| White Carrots | Experimental | Participants will eat 100g (cooked weight) of white carrots per day for 6 weeks Receives: Dietary Supplement: White carrots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lymphocyte DNA damage from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out (no carrots or oats).
Lymphocyte DNA damage will be measured by comet assay. Comet 'tail length' represents the number of single strand breaks in the DNA that leave the nucleus when the cells undergo electrophoresis - the longer the 'tail' the more strand breaks. Tail length will be measured from lymphocyte DNA samples at baseline, after 6 weeks of the intervention period and again after 6 weeks of the wash out period. Statistical analysis will compare the extent of damage after supplementation of carrots or oats in the diet (intervention period) to damage at baseline and to damage after the wash out period.
Measured: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Change in inflammation from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out.
Inflammatory markers (blood CRP, TNF-alpha, IL-6 and urine PE2M) will be measured by ELISA assay. at baseline, after 6 weeks of the intervention period and again after 6 weeks of the wash out period. Statistical analysis will compare the inflammation levels after supplementation of carrots or oats in the diet (intervention period) to inflammation at baseline and inflammation after the wash out period.
Measured: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Secondary outcomes (1)
Analysis of faecal water from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out to determine toxicity to colon epithelial cells.
Faecal samples will be collected at baseline, after intervention and after wash-out. Faecal water will be removed from the samples and used in cell culture with colon epithelial cells. After culture, the cells will undergo comet assay to determine the amount of strand breaks that occur in each of the three treatments. Tail length will be measured from colon epithelial cell DNA samples from baseline, intervention period and the wash out period samples. Statistical analysis will compare the extent of damage to epithelial cells after exposure to faecal water made during supplementation of carrots or oats in the diet (intervention period) to damage with baseline and wash out period faecal water.
Measured: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA DamageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Brandt, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696811
- Sponsor's protocol ID
- VEG_01
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised 6-week, Parallel Group, Placebo Controlled Intervention Trial to Investigate the Effects of White Carrots on Inflammatory Markers and Lymphocyte DNA Damage
- ClinicalTrials.gov ID
- NCT02696811
- Acronym / sponsor ID
- VEG_01
- Conditions
- DNA Damage, Inflammation
- Keywords
- cancer, inflammation, dietary intervention trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Mar 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.
Studies have shown that certain compounds inside vegetables can reduce the risk of cancer. Carrots in particular have an association with reduced incidence of colorectal, bladder and breast cancer. Compounds in carrots, called polyacetylenes, have been studied in isolated cells that have shown a reduction in cancer cells as well as inflammatory markers which have been associated with an increased risk of cancer. These polyacetylenes have not been well studied in the human body and it is unclear whether they are able to affect the biomarkers of health (disease) including DNA damage and inflammatory markers. The aim of this research project is to determine whether eating a portion of white carrots every day for 6 weeks can lead to a reduction in DNA damage and inflammatory markers compared to a control period of 6 weeks consuming a polyacetylene-free diet and a control food of a high fibre oat biscuit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oat biscuits | Placebo comparator | Dietary Supplement: Oat biscuitsParticipants will eat 3 oat biscuits per day for 6 weeks |
| White Carrots | Experimental | Dietary Supplement: White carrotsParticipants will eat 100g (cooked weight) of white carrots per day for 6 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non -smokers
- BMI between 18.5 and 30
Key exclusion criteria (5 listed)
- smoking
- taking anti-inflammatories
- taking aspirin or aspirin-like drugs
- antibiotic use in the last 3 months
- metabolic conditions or conditions affecting the metabolism or digestion
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 |
|---|---|---|
| White carrotsAlso: Falcarinol, falcarindiol, falcarindiol-3-acetateWhite carrots contain compounds called polyacetylenes, including falcarinol, falcarindiol and falcarindiol-3-acetate. | Dietary supplement | White Carrots |
| Oat biscuitsThe 3 oat biscuits contain the same amount of fibre and sugar as the white carrot but without the polyacetylenes. | Dietary supplement | Oat biscuits |
Primary outcome
Change in lymphocyte DNA damage from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out (no carrots or oats).
Time frame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Lymphocyte DNA damage will be measured by comet assay. Comet 'tail length' represents the number of single strand breaks in the DNA that leave the nucleus when the cells undergo electrophoresis - the longer the 'tail' the more strand breaks. Tail length will be measured from lymphocyte DNA samples at baseline, after 6 weeks of the intervention period and again after 6 weeks of the wash out period. Statistical analysis will compare the extent of damage after supplementation of carrots or oats in the diet (intervention period) to damage at baseline and to damage after the wash out period.
Change in inflammation from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out.
Time frame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
Inflammatory markers (blood CRP, TNF-alpha, IL-6 and urine PE2M) will be measured by ELISA assay. at baseline, after 6 weeks of the intervention period and again after 6 weeks of the wash out period. Statistical analysis will compare the inflammation levels after supplementation of carrots or oats in the diet (intervention period) to inflammation at baseline and inflammation after the wash out period.
1 secondary outcome
Analysis of faecal water from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out to determine toxicity to colon epithelial cells.
Time frame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
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 31 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Kirsten Brandt principal investigator
Newcastle 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 White carrots and Oat biscuits in people with DNA Damage and Inflammation, run by Newcastle 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 5 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 31 Oct 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. 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?
Change in lymphocyte DNA damage from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out (no carrots or oats). (time frame: Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)). The study lists 2 primary outcomes in all. 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 31 Oct 2017.