NCT07429201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

23 days

First QC Date

February 16, 2026

Last Update Submit

March 13, 2026

Conditions

Hydration StatusDietary Intake

Keywords

Ramadaniftarbeveragefluid intakefeelings of well beinghydrationfastingSaudi Arabia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Electrolyte-carbohydrate beverage

EXPERIMENTAL

A beverage with electrolytes (sodium, potassium, chloride) and carbohydrates

Other: Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes

Water

ACTIVE COMPARATOR

Plain commercial bottled water

Other: Witnessed ad libitum water intake over 120 minutes

Interventions

Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutesOTHER

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.

Electrolyte-carbohydrate beverage
Witnessed ad libitum water intake over 120 minutesOTHER

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.

Water

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safa Pioneer Clinic, Amna Bint Wahb St.

Jeddah, Al Mohammadiyyah, 23623, Saudi Arabia

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Salah Fouad, MD

    Safa Pioneer Clinic, Jeddah Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 24, 2026

Study Start

February 11, 2026

Primary Completion

March 6, 2026

Study Completion

March 6, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)