CompletedNot Applicable

Salt Intake, Hydration Status and Gastrointestinal Discomfort During Fasting

United Kingdom23 participantsStarted 2023-02-14

Plain-language summary

This study is part of a hyperhydration project and it has been designed based on a scoping review (Hyperhydration in healthy adults: a scoping review on different methodologies and vehicles utilized) and a previous study (Dietary patterns and gastrointestinal discomfort during Ramadan in a UK Muslim population). The current study aims to examine the impact of different levels of salt intake (6 \& 9 grams) with \[15 milliliters per kilogram of bodyweight (ml/ kg/ bw)\] of water intake during 7 hours of dry fasting compared to a control group (3g salt) under the state of water balance (euhydrated). A previous study and a review by the authors highlighted the potential negative impact of salt and fasting on gastrointestinal (GI) discomfort; hence, the potential negative side effects on gastrointestinal (GI) discomfort during the intervention period will be investigated. By studying a hyperhydration protocol, this research will help the population to reduce dehydration during dry fasting. By doing so, it may improve the quality of life during Ramadan fasting.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 45 * BMI between 18.5 and 29.9 * No higher (140/90mmHg) or lower (80/60mmHg) blood pressure * Non-pregnant or lactating * No diabetes (type 1 \& 2) * No gastrointestinal disease such as inflammatory bowel disease (IBD) or Irritable bowel syndrome (IBS) * No disease including the common cold and high cholesterol (total cholesterol above 5 mmol/l) * No covid symptoms * No allergy to the food in the meal list and tomatoes Exclusion Criteria: * Aged \<18 or \>45 years * BMI between \<18.5 or \> 29.9 * Higher (\>140/90mmHg) or lower (\<80/60mmHg) blood pressure * Pregnant or lactating * Having diabetes (type 1 \& 2) * Having gastrointestinal disease such as inflammatory bowel disease (IBD) or Irritable bowel syndrome (IBS) * Having disease including the common cold and high cholesterol (total cholesterol above 5 mmol/l) * Having covid symptoms * Having allergy to the food in the meal list and tomatoes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total urine production baseline

Timeframe: 0 hour

Total urine production 1 hour

Timeframe: 1 hour

Total urine production 2 hours

Timeframe: 2 hours

Total urine production 3 hours

Timeframe: 3 hours

Total urine production 4 hours

Timeframe: 4 hours

Total urine production 5 hours

Timeframe: 5 hours

Total urine production 6 hours

Timeframe: 6 hours

Total urine production 7 hours

Timeframe: 7 hours

Trial details

NCT IDNCT05839860

SponsorOxford Brookes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

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