Improvement of Functional Constipation With Kiwifruit Intake in a Mediterranean Patient Population: Open Non-controlled and Non-randomized Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Proportion of patients with three or more stools per week
研究概览
简要总结
Constipation is a symptom suffered by a large number of people, due to multifactorial causes. Some studies have proven that modifying lifestyle reduces the risk of constipation, with high-fibre diets being less prone to constipation. Kiwifruit consumption, improves functional constipation and some studies consistently report an increase in the frequency and ease of defecation, stool volume and softness.
Although literature suggests kiwifruit consumption improves constipation symptoms, no studies have been carried out in adults and in Mediterranean patient populations, characteristic for its differential nutritional habits. The aim of the present study was to test the effect of kiwifruit consumption on functional constipation in a Spanish adult population.
详细描述
Worldwide general population prevalence of constipation ranges from 0.7% to 79% (median 16%). Some factors associated with constipation are sex, with higher prevalence in females (especially during pregnancy, and age; in general it becomes gradually more prevalent after the 70 years of age, in women the increase is considerable from a young age (18-23 years old) to middle age (45-50 years old).
Constipation is characterized by difficult or infrequent deposition, often accompanied by excessive straining during bowel movement or sensation of incomplete evacuation. In most cases, there is no underlying organic cause, and constipation is labelled as chronic idiopathic constipation and as a functional digestive disorder. The Rome III criteria is a useful tool for the diagnosis of constipation that highlights the chronic nature of the disorder and the importance of symptoms beyond the infrequency of bowel movements.
Understanding its causes, prevention, and treatment will help most people find constipation relief. An individual's medical history is very important in determining a constipation diagnosis. Primary healthcare professionals should enquire about dietary habits and lifestyle, pharmacological and toxic habits, complementary and alternative medicine, physiological bowel habits, use of laxatives and past disease history
Aims:
To test the effect of kiwifruit consumption on functional constipation in a Spanish adult population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more of the following:
- •Straining during at least 25% of defecations Lumpy or hard stools in at least 25% of defecations Sensation of incomplete evacuation for at least 25% of defecations Sensation of anorectal obstruction/blockage for at least 25% of defecations Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital evacuations and support of the pelvic floor) Fewer than three defecations per week; and
- •Loose stools are rarely present without the use of laxatives;
- •Insufficient criteria for irritable bowel syndrome;
- •Criteria fulfilled for at least 3 months with symptom onset at least 6 months before diagnosis.
排除标准
- •Patients with allergy to kiwifruit or latex
- •Patients who have undergone gastro-intestinal surgery in the last year
- •Patients taking medication to treat constipation
- •Patients with oncological disease
- •Patients taking narcotic medication
- •Patients with organic gastroenterological diseases (except non- complicated diverticulosis).
结局指标
主要结局
Proportion of patients with three or more stools per week
时间窗: Five weeks
Number of patients with three or more stools among participants Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose
Frequency of stool per week
时间窗: Five weeks
Number of diary depositions recorded in a self adminitered questionnaire designed for this purpose
Number of responders (increase of ≥ 1 stool per week)
时间窗: Five weeks
Number of people increasing more ≥ 1stool for week recorded in a self adminitered questionnaire designed for this purpose
次要结局
- Volume of stool(Five weeks)
- Satisfaction of the patient.(Five weeks)
- Ease of defecation(Five weeks)
- Consistency of stool(Five weeks)