Hydration StatusNCT07429201
Comparing an Electrolyte-Carbohydrate Beverage to Water During Ramadan
A study testing Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes and Witnessed ad libitum water intake over 120 minutes in people with Hydration Status and Dietary Intake, run by PepsiCo Global R&D at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status, Dietary Intake
- What is being tested?
- Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes and Witnessed ad libitum water intake over 120 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Feb 2026to 6 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Safa Pioneer Clinic, Amna Bint Wahb St.
Jeddah, Al Mohammadiyyah, 23623
About this study
Official title: 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.
- Conditions
- Hydration Status, Dietary Intake
- Being tested
- Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes, Witnessed ad libitum water intake over 120 minutes
- Keywords
- Ramadan, iftar, beverage, fluid intake, feelings of well being, hydration, fasting, Saudi Arabia
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrolyte-carbohydrate beverage | Experimental | A beverage with electrolytes (sodium, potassium, chloride) and carbohydrates Receives: Other: Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes |
| Water | Active comparator | Plain commercial bottled water Receives: Other: Witnessed ad libitum water intake over 120 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water
Total volume consumed in milliliters
Measured: From iftar to 120 minutes
Secondary outcomes (2)
To characterize habitual fluid intake patterns before Ramadan using 24-hour dietary recall
Measured for usual non-fasting day
Measured: 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
Measured: 24 hour period during Ramadan fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start11 Feb 2026
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salah Fouad, MD, Principal investigator, Safa Pioneer Clinic, Jeddah Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429201
- Sponsor's protocol ID
- PEP-2517
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Crossover Study Comparing an Electrolyte-Carbohydrate Beverage to Water During Ramadan
- ClinicalTrials.gov ID
- NCT07429201
- Acronym / sponsor ID
- PEP-2517
- Conditions
- Hydration Status, Dietary Intake
- Keywords
- Ramadan, iftar, beverage, fluid intake, feelings of well being, hydration, fasting, Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrolyte-carbohydrate beverage | Experimental | Other: Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutesA beverage with electrolytes (sodium, potassium, chloride) and carbohydrates |
| Water | Active comparator | Other: Witnessed ad libitum water intake over 120 minutesPlain commercial bottled water |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutesParticipants 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. | Other | Electrolyte-carbohydrate beverage |
| Witnessed ad libitum water intake over 120 minutesParticipants 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. | Other | Water |
Primary outcome
To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water
Time frame: From iftar to 120 minutes
Total volume consumed in milliliters
2 secondary outcomes
To characterize habitual fluid intake patterns before Ramadan using 24-hour dietary recall
Time frame: 24 hour period prior to Ramadan fasting
To characterize habitual fluid intake patterns during Ramadan using 24-hour dietary recall
Time frame: 24 hour period during Ramadan fasting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Fouad, MD principal investigator
Safa Pioneer Clinic, Jeddah Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Witnessed ad libitum electrolyte-carbohydrate beverage intake over 120 minutes and Witnessed ad libitum water intake over 120 minutes in people with Hydration Status and Dietary Intake, run by PepsiCo Global R&D at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare post-fast fluid intake when breaking the fast with an Electrolyte-Carbohydrate beverage versus water (time frame: From iftar to 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.