Dietary Carbohydrate Effects on GERD in Obese Veterans: Nutritional or Hormonal?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Gastroesophageal pH
研究概览
简要总结
4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.
详细描述
delayed due to COVID related research shutdown
Specific Hypothesis: The preliminary findings suggest a physiological mechanism between dietary intake and GERD that may be related to type of dietary carbohydrate intake (complex vs simple carbohydrate). The investigators hypothesize that modifying the type of dietary carbohydrate consumed - by reducing the proportion of simple carbohydrate (sugars) consumed - will reduce or resolve GERD symptoms and medication use in obese Veterans with chronic GERD. The investigators further hypothesize that the mechanistic effects of reducing simple carbohydrate intake is related to either: a) improved dietary fiber intake and/or glycemic load, and thus, reduced amount and duration of esophageal acid exposure; and/or b) improved insulin sensitivity which would positively influence the function of key gastrointestinal hormones (ie, gastrin, glucagon, GLP-1, ghrelin11) that regulate gastric motility and/or lower esophageal sphincter function.
Aim 1: To determine effects of dietary carbohydrate consumed (amount and type) on percent time with esophageal pH < 4.0, as well as number of reflux episodes, GERD symptoms and GERD medication use, in 200 obese Veterans who have chronic high frequency of GERD symptoms. To meet this aim the investigators will use a randomized controlled trial in which the investigators manipulate amount of total and simple dietary carbohydrate intake for duration of 9 weeks.
Aim 2: To assess associations between GERD resolution variables and factors related to potential mechanisms by which modifying dietary carbohydrate intake could resolve/reduce GERD in obese Veterans.
2a: The investigators will investigate associations related to whether the effect is nutritionally mediated by measuring change in dietary fiber load and dietary glycemic load, and thus, whether these changes are related to improved gastric acid secretion (% time pH < 4), gastric motility, and/or the other parameters that comprise the Johnson-DeMeester score.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or over BMI 30-39.9 GERD
排除标准
- •History of type 1 diabetes
- •Hernia or strictures
- •Gastroparesis
- •Extra-esophageal GERD
- •Barrett's esophagus or Esophageal adenocarcinoma
- •History of gastric or bariatric or esophageal surgery, radiation or cancer
- •History of gastrointestinal malabsorption
- •Alcohol averaging > 2 drinks per day during past 3 months
- •Pregnancy / Lactation
结局指标
主要结局
Gastroesophageal pH
时间窗: 24 hours
ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs
次要结局
- Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score(9 weeks)
- Gastroesophageal Scale Assessment Symptom (GSAS) Score(9 weeks)
