Effects of Diet and Alcohol on Fullness, Reflux and Dyspeptic Symptoms After Meals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Number of dyspeptic symptoms
研究概览
简要总结
Reflux and dyspeptic symptoms are common affecting 10-20% of the population on a regular basis. Reflux symptoms such as heartburn and regurgitation are caused by the return of acid or non-acid gastric contents into the esophagus. Dyspeptic symptoms are caused by abnormal gastric relaxation (impaired accommodation) or increased sensitivity of the stomach to distension during the meal.
The effects of diet on gastrointestinal function are debated and the efficacy of dietary management for digestive symptoms has not been established. Epidemiological studies suggest an effect; however, it is not possible to distinguish the effects of fat intake and total energy (i.e. calorie) intake in this work. This issue has been addressed by small physiological studies. The results show that esophageal acid exposure was related to total calorie intake but not to fat content. In contrast, the number of reflux symptoms was 40% higher after the high-fat than the low-fat meals. Similar findings were found for the relationship between gastric distension, fullness and dyspeptic symptoms by Magnetic Resonance Imaging. Thus, it appears that fat does not cause digestive dysmotility but heightens sensitivity to visceral events and so increases the number and severity of symptoms reported by patients. As yet, these findings have not been confirmed in larger, more representative surveys.
Similar to the effects of food, there are inconsistent findings regarding the effects of alcohol on gastro-esophageal reflux (GER) and gastric function. Physiological studies have noted delayed gastric emptying and an increase in reflux events when alcohol is taken with food. However, larger surveys have not confirmed that alcohol triggers reflux or dyspeptic symptoms.
The proposed observational, dietary study with cross-over design will assess the independent effects of energy intake (i.e. calorie load) and fat intake on gastric fullness, the number and severity of reflux and dyspeptic symptoms after meals. The effect of alcohol on symptoms after the high calorie, high fat meals will also be documented. The study population of senior academics attending a conference are likely to have a relatively high prevalence of risk factors for gastro-esophageal reflux disease (GERD) being predominantly male, with an older age and a larger waist circumference than average in the general community. This will increase study power and relevance of the findings.
The results will provide new information concerning the impact of dietary factors and alcohol on digestive symptoms after meals. This data will inform future guidelines for the dietary management of patients with reflux and dyspeptic symptoms after meals which will be relevant in both primary and secondary care.
详细描述
This is an observational, dietary study with cross-over design. Restaurant style meals and beverages are provided to faculty and delegates attending the Ascona II conference that agree to participate and provide written consent. Approximately 120 participants are expected to be recruited.
On four consecutive days the evening meal served will vary in calorie load and fat content using the established, partially balanced study design applied in previous studies. On the first three days fruit juice will be served, whereas, on the final day, an alcoholic beverage with the same acidity and number of calories will be served. All meals will have the same size and salt content. Controlling for all these parameters will reduce possible confounding factors in the analysis.
- High calorie (1200 kcal), High fat (50% energy), 400 ml juice (230 kcal)
- High calorie (1200 kcal), Low fat (20% energy), 400 ml juice (230 kcal)
- Low calorie (600 kcal), Low fat (20% energy), 400 ml juice (230 kcal)
- High calorie (1200 kcal), High fat (50% energy), 300 ml wine (40 g alcohol, 230 kcal), 100 ml water Note: The order of meals on day 1-3 will be fixed, but not necessarily in the order above. Meal constituents will not be disguised.
Note: Testing digestive symptoms in response to diet on successive days is possible because clinical physiological studies have shown no evidence of a sequence effect in previous studies using similar test meals.
An alginate-antacid preparation will be available as required for acute relief of any reflux or dyspeptic symptoms (Gaviscon Liquid, Reckitt Benckiser (available across-the-counter for this indication in Switzerland)). No participant is required to take this preparation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be faculty and delegates attending the "Ascona II: Advances in clinical measurement of gastrointestinal motility and function" conference.
排除标准
- •Age < 18,
- •special dietary requirements incompatible with meals served at congress hotel restaurant,
- •participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable),
- •individuals unwilling to provide written informed consent,
- •inability to follow the procedures of the study, e.g. due to language problems (all study documents in English).
- •Participants with a history of alcohol dependency or medical conditions that may be exacerbated or affected by alcohol intake are allowed to participate but are instructed not to drink the alcohol provided with the high calorie, high fat test meal on day 4.
结局指标
主要结局
Number of dyspeptic symptoms
时间窗: Participants will be followed for the duration of the conference, an expected average of 4 days
Similar to "Pharmacokinetic outcome measures" the occurrence of dyspeptic symptoms after each dinner will be summed up and compared between different dinners.
Number of reflux symptoms
时间窗: Participants will be followed for the duration of the conference, an expected average of 4 days
Similar to "Pharmacokinetic outcome measures" the occurrence of reflux symptoms after each dinner will be summed up and compared between different dinners.
次要结局
- The sensation of fullness measured by a visual-to-analogue scale from 0 to 100(Participants will be followed at time points -30 min (before dinner) and at 0, 30, 60, 90, 120, 150, 180 min (after dinner) for 4 consecutive days)
- The severity of dyspeptic symptoms measured by a visual-to-analogue scale from 0 to 100(Participants will be followed at time points -30 min (before dinner) and at 0, 30, 60, 90, 120, 150, 180 min (after dinner) for 4 consecutive days)
- The severity of reflux symptoms measured by a visual-to-analogue scale from 0 to 100(Participants will be followed at time points -30 min (before dinner) and at 0, 30, 60, 90, 120, 150, 180 min (after dinner) for 4 consecutive days)