NCT05520411已完成不适用
Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Perceived Changes in Bloating and Stomach Distention
研究概览
简要总结
Flatter Me is a product that includes digestive enzymes in a way to support digestion of macronutrients and their constituents and provides herbs traditionally used for digestive health support. This trial aims to test Flatter Me against a placebo pill to examine differences in both subjective outcomes (feelings of bloating and indigestion) and changes in waist circumference (abdominal distension) after eating a test meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self Report bloating or stomach distension at least once per day after eating
排除标准
- •Females who are pregnant or breastfeeding
- •Currently taking any prescribed medication meant to treat gut health
- •Currently taking any medication for fluid balance (i.e., Aldactone)
- •Currently suffers from any pre-existing condition that would prevent them from adhering to the protocol.
- •Currently suffers from any pre-existing condition that would prevent them from consuming cheese pizza.
- •Use of an antibiotic in the previous 3 months.
- •Taking an iron supplement with > 65mg of iron in the last week.
- •Diagnosed with any of IBS, chronic constipation, GERD, Crohn's Disease, ulcerative colitis, celiac disease, liver disease, kidney disease, heart failure.
- •Lactose Allergy or Intolerance
- •Any food allergies
- •Current smoker
- •Wears dentures
结局指标
主要结局
Perceived Changes in Bloating and Stomach Distention
时间窗: 1 Week
Questionnaires will be administered to participants at multiple time points before and after eating a test meal. Symptom severity is rated on a scale of 0 (None) to 4 (Extremely Severe)
次要结局
- Visible changes in stomach distension.(1 week)
研究者
研究点 (2)
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