The Effects of Foods on Cell Damage Study

Sponsor
Newcastle University (Other)
Overall Status
Completed
CT.gov ID
NCT02696811
Collaborator
(none)
38
1
2
11
3.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: White carrots
  • Dietary Supplement: Oat biscuits
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
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
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Oat biscuits

Participants will eat 3 oat biscuits per day for 6 weeks

Dietary Supplement: Oat biscuits
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

Dietary Supplement: White carrots
White carrots contain compounds called polyacetylenes, including falcarinol, falcarindiol and falcarindiol-3-acetate.
Other Names:
  • Falcarinol
  • falcarindiol
  • falcarindiol-3-acetate
  • Outcome Measures

    Primary Outcome Measures

    1. 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). [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.

    2. Change in inflammation from baseline after 6 weeks of carrot or oat supplementation in the diet, and after 6 weeks wash out. [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.

    Secondary Outcome Measures

    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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Agriculture Building, Newcastle University Newcastle upon Tyne Tyne and Wear United Kingdom NE1 7RU

    Sponsors and Collaborators

    • Newcastle University

    Investigators

    • Principal Investigator: Kirsten Brandt, Newcastle University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Newcastle University
    ClinicalTrials.gov Identifier:
    NCT02696811
    Other Study ID Numbers:
    • VEG_01
    First Posted:
    Mar 2, 2016
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Newcastle University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 31, 2017