A Randomized, Open-Label, Crossover Study Comparing an Electrolyte-Carbohydrate Beverage to Water During Ramadan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water
研究概览
简要总结
The purpose of this study is to explore the effects of breaking the fast (iftar) during Ramadan with different beverages on dietary and beverage intake patterns and related measurements during the hours after iftar and into the next morning, as well as participants' self-reported feelings such as thirst, mood, and overall wellbeing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Muslim adults aged 18-50 years who are observing Ramadan fasting.
- •Able and willing to provide written informed consent.
- •Able to speak, read, and understand Arabic or English sufficiently to comply with study procedures.
- •Willing and able to consume the electrolyte-carbohydrate (EC) beverage and water during study visits.
- •Demonstrates product acceptability during screening, defined as overall liking (OL) score ≥ 6 following consumption of a 50 mL sample of the EC beverage (9-point hedonic scale).
- •Self-reported as generally healthy with no known condition that would interfere with participation.
- •Able to comply with study procedures and attend two on-site intervention visits.
- •Willing and able to maintain usual daytime sleep patterns during the intervention period (i.e., avoid intentional major changes to sleep schedule) from 48 hours prior to each intervention visit until the following morning assessment.
排除标准
- •Any medical condition or medication use known to affect fluid balance/hydration status, including but not limited to diuretics, laxatives, weight-loss medications.
- •History of clinically significant cardiovascular, renal, endocrine, or metabolic disease.
- •Pregnant or breastfeeding (lactating) females, or females who plan to become pregnant during the study period.
- •Engagement in heavy/vigorous exercise within 24 hours prior to any study visit.
- •Participation in any PepsiCo-sponsored clinical trial within the previous 6 months.
- •Participation in any other interventional clinical trial within the previous 30 days.
研究组 & 干预措施
Electrolyte-carbohydrate beverage
A beverage with electrolytes (sodium, potassium, chloride) and carbohydrates
干预措施: Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes (Other)
Water
Plain commercial bottled water
干预措施: Witnessed ad libitum water intake over 120 minutes (Other)
结局指标
主要结局
To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water
时间窗: From iftar to 120 minutes
Total volume consumed in milliliters
次要结局
- To characterize habitual fluid intake patterns before Ramadan using 24-hour dietary recall(24 hour period prior to Ramadan fasting)
- To characterize habitual fluid intake patterns during Ramadan using 24-hour dietary recall(24 hour period during Ramadan fasting)