Dietary Intake, Hydration Status
Conditions
Keywords
Ramadan, iftar, beverage, fluid intake, feelings of well being, hydration, fasting, Saudi Arabia
Brief summary
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.
Interventions
OTHERWitnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes
Participants will consume the study electrolyte-carbohydrate beverage ad libitum over a 120-minute period following Iftar under supervised conditions. No other foods or beverages will be permitted during the first 120 minutes.
OTHERWitnessed ad libitum water intake over 120 minutes
Participants will consume water ad libitum over a 120-minute period following Iftar under supervised conditions. No other foods or beverages will be permitted during the first 120 minutes.
Sponsors
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Muslim adults aged 18-50 years who are observing Ramadan fasting. 2. Able and willing to provide written informed consent. 3. Able to speak, read, and understand Arabic or English sufficiently to comply with study procedures. 4. Willing and able to consume the electrolyte-carbohydrate (EC) beverage and water during study visits. 5. 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). 6. Self-reported as generally healthy with no known condition that would interfere with participation. 7. Able to comply with study procedures and attend two on-site intervention visits. 8. 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.
Exclusion criteria
1. Any medical condition or medication use known to affect fluid balance/hydration status, including but not limited to diuretics, laxatives, weight-loss medications. 2. History of clinically significant cardiovascular, renal, endocrine, or metabolic disease. 3. Pregnant or breastfeeding (lactating) females, or females who plan to become pregnant during the study period. 4. Engagement in heavy/vigorous exercise within 24 hours prior to any study visit. 5. Participation in any PepsiCo-sponsored clinical trial within the previous 6 months. 6. Participation in any other interventional clinical trial within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water | From iftar to 120 minutes | Total volume consumed in milliliters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To characterize habitual fluid intake patterns before Ramadan using 24-hour dietary recall | 24 hour period prior to Ramadan fasting | Measured for usual non-fasting day |
| To characterize habitual fluid intake patterns during Ramadan using 24-hour dietary recall | 24 hour period during Ramadan fasting | Measured for a usual fasting day |
Countries
Saudi Arabia
Contacts
PRINCIPAL_INVESTIGATORSalah Fouad, MD
Safa Pioneer Clinic, Jeddah Saudi Arabia
Outcome results
None listed