Comparing an Electrolyte-Carbohydrate Beverage to Water During Ramadan

A Randomized, Open-Label, Crossover Study Comparing an Electrolyte-Carbohydrate Beverage to Water During Ramadan

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.

Study Overview

• Status: Completed
• Conditions: Dietary Intake; Hydration Status
• Intervention / Treatment: Other: Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes; Other: Witnessed ad libitum water intake over 120 minutes

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Mohammadiyyah
    • Jeddah, Al Mohammadiyyah, Saudi Arabia, 23623
      • Safa Pioneer Clinic, Amna Bint Wahb St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrolyte-carbohydrate beverage; A beverage with electrolytes (sodium, potassium, chloride) and carbohydrates	Other: Witnessed 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.
Active Comparator: Water; Plain commercial bottled water	Other: Witnessed 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water	Total volume consumed in milliliters	From iftar to 120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize habitual fluid intake patterns before Ramadan using 24-hour dietary recall	Measured for usual non-fasting day	24 hour period prior to Ramadan fasting
To characterize habitual fluid intake patterns during Ramadan using 24-hour dietary recall	Measured for a usual fasting day	24 hour period during Ramadan fasting

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Salah Fouad, MD, Safa Pioneer Clinic, Jeddah Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Actual): March 6, 2026
• Study Completion (Actual): March 6, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: fasting; Saudi Arabia; beverage; Ramadan; hydration; fluid intake; iftar; feelings of well being
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Fasting
• Other Study ID Numbers: PEP-2517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No