Berry Intake - Effects on Systemic and Oral Inflammation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in the extent of gingivitis, as determined by severity of gingival bleeding, before and after study procedures.
研究概览
简要总结
The purpose of this study is to determine whether intake of berry powder effective in the treatment of systemic and oral inflammation.
详细描述
Summary About 10-15 % of the adult population in Sweden suffers from periodontitis, which is an inflammatory response to certain oral bacteria. The first stage of periodontitis is termed gingivitis, which is clinically defined by swollen tissue, redness and bleeding in the gingiva. If the inflammatory process could be attenuated, this would greatly reduce the risk of developing periodontitis.
Diet is of importance for the development and prevention of chronic diseases. Berries contain compounds that can act as anti-inflammatory agents and this bioactivity may reduce the risk of disease. A recent meta-analysis of publications in this area revealed a dearth of experimental and clinical data on the impact of berry intake on inflammatory conditions. Studies which detail berry intake/dosage and period of dosage to exert an effect is particularly lacking, in terms of the positive effects of berries on anti-inflammatory conditions. The purpose of this project is to:
- Demonstrate the impact of daily intake of freeze-dried berries on the clinical degree of chronic inflammation by studying changes in the degree of gingivitis.
- To study the presence of pro- and anti-inflammatory markers locally in gingival tissue, saliva and through analysis of serum samples.
- To analyze dose response relationship for different berry powders by investigating clinical and biomedical effect.
Background Many diseases have a significant inflammatory pathogenesis which can be difficult to control. In traditional medicine symptoms and inflammatory processes are treated with pharmaceuticals. Many pharmaceuticals show side-effects that have economic and environmental consequences both for the individual and the environment. It has for centuries been known that plants have anti-inflammatory and healing effects. An early example of how plants came in use for medical treatment is the work of Carl von Linné and his practice as a botanist and physician.
In modern times complimentary alternative medicine has claimed that intake of fruit and berries in different compositions has anti-inflammatory effects. Some of these claims have been difficult to evaluate since studies to highlight anti-inflammatory benefit have often not been well conducted. There is a conspicuous lack of data on clinically effective doses of plant extracts. The Swedish National Food Agency contends that the daily intake of vegetables, fruits and berries should be 500 grams for adults, although few people in Sweden reach these recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •minimum of 20 teeth
- •bleeding on probing >25 %
- •participate in routine dental examinations
排除标准
- •on anti-inflammatory medication
- •current treatment with antibiotics or intake of antibiotics 3 months before participating in the study
- •pregnancy
- •unwilling to refrain from nutraceuticals during the study period
- •unwilling to give detailed information on diet intake during the study period
研究组 & 干预措施
Potato starch
Potato powder will be incorporated in the placebo product.
干预措施: Berry powder (Dietary Supplement)
Berry powder
Several different berry powders including rose hip, bilberry, blackcurrant, sea buckthorn, and lingonberry will be prepared and studied.
干预措施: Berry powder (Dietary Supplement)
结局指标
主要结局
Changes in the extent of gingivitis, as determined by severity of gingival bleeding, before and after study procedures.
时间窗: Once a week over five weeks.
次要结局
- Change in levels of vascular endothelial growth factor in serum, saliva and gingival fluid in relation to gingival inflammation, as determined by severity of gingival bleeding, before and after study procedures.(Once a week over five weeks.)
- Change in levels of vascular endothelial growth factor in serum, saliva and gingival fluid in relation to amount of berry intake before and after study procedures.(Once a week over five weeks.)
研究者
Cecilia Widen
Researcher
Kristianstad University
