Randomised 6-week, Parallel Group, Placebo Controlled Intervention Trial to Investigate the Effects of White Carrots on Inflammatory Markers and Lymphocyte DNA Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non -smokers
- •BMI between 18.5 and 30
排除标准
- •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
结局指标
主要结局
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).
时间窗: 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.
时间窗: 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.
次要结局
- 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))