- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696811
The Effects of Foods on Cell Damage Study
October 27, 2017 updated by: Newcastle University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
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
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
- Agriculture Building, Newcastle 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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non -smokers
- BMI between 18.5 and 30
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Oat biscuits
Participants will eat 3 oat biscuits per day for 6 weeks
|
The 3 oat biscuits contain the same amount of fibre and sugar as the white carrot but without the polyacetylenes.
|
Experimental: White Carrots
Participants will eat 100g (cooked weight) of white carrots per day for 6 weeks
|
White carrots contain compounds called polyacetylenes, including falcarinol, falcarindiol and falcarindiol-3-acetate.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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.
|
Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
Baseline measures then 2 periods of 6 weeks (baseline, intervention and wash out)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kirsten Brandt, Newcastle 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
October 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
February 17, 2016
First Submitted That Met QC Criteria
February 25, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
October 27, 2017
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEG_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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