HealthyNCT05839860
Salt Intake, Hydration Status and Gastrointestinal Discomfort During Fasting
A study testing Salt 3 g, Salt 6 g and Salt 9 g in people with Healthy, run by Oxford Brookes University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salt 3 g, Salt 6 g and Salt 9 g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2023to 31 Jul 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes Centre for Nutrition and Health
Oxford, OX3 0BP
About this study
Official title: The Effect of Low and High Salt Intake on Hydration Status and Gastrointestinal Discomfort During Seven Hours of Dry Fasting
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.
Read the detailed description
Dry fasting has been reported to cause changes in body weight, lipid profile, blood pressure, glucose level, metabolism, hormones homeostasis, and hydration status. A scoping review by the investigators highlighted that dehydration had been linked to changes in plasma volume and osmolality (concentration of all chemical particles), urine volume and osmolality, blood pressure, glucocorticoid hormones, body weight loss, negative impact on mood, irritability, short-term memory, and work productivity. It has been reported that prolonged dry fasting can contribute to a loss of up to 1.5 kg in body weight on the day after fasting. This weight loss is associated with loss of body water.
Hyperhydration (overhydration) has not yet been defined. However, any improvement in the fluid matrix in the plasma volume is considered hyperhydration. Simulating hyperhydration strategies, such as those used by athletes competing in long-distance events and in hot environments, has the potential to reduce the level of dehydration during dry fasting.
Sodium and water intake have essential roles in maintaining and improving the fluid matrix in plasma. By investigating the relationship between sodium and water intake on biomarkers such as urine sodium concentration, blood pressure, speed of urine production, urine colour, urine specific gravity, and net body fluid balance, it is possible to distinguish the impact of hyperhydration protocols on hydration levels.
The primary aim of this study is to examine the impact of salt intake (6 \& 9 g/l) on the level of hydration by measuring urine sodium, urine potassium, urine production, and changes in body weight compared to the control group during 8 hours of dry fasting. The secondary outcome of this study will be the impact of the hyperhydration protocol on GI discomfort.
- Conditions
- Healthy
- Being tested
- Salt 3 g, Salt 6 g, Salt 9 g
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt 3 gOther
Placebo group taking a breakfast meal and 3g salt on tomatoes before fasting for 7 hours
Salt 6 gOther
Intervention group taking a breakfast meal and 6g salt on tomatoes plus 1 L water before fasting for 7 hours
Salt 9 gOther
Intervention group taking a breakfast meal and 9g salt on tomatoes plus 1 L water before fasting for 7 hours
| Study group | Role | What they receive |
|---|---|---|
| 3 g salt | Placebo comparator | Tomatoes with 3 g salt Receives: Other: Salt 3 g |
| 6 g salt | Experimental | Tomatoes with 6 g salt and 1 L of water Receives: Other: Salt 6 g |
| 9 g salt | Experimental | Tomatoes with 9 g salt and 1 L of water Receives: Other: Salt 9 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total urine production baseline
Volume of urine produced at baseline
Measured: 0 hour
Total urine production 1 hour
Volume of urine produced at 1 hour after starting fasting
Measured: 1 hour
Total urine production 2 hours
Volume of urine produced at at 2 hours after starting fasting
Measured: 2 hours
Total urine production 3 hours
Volume of urine produced at at 3 hours after starting fasting
Measured: 3 hours
Total urine production 4 hours
Volume of urine produced at at 4 hours after starting fasting
Measured: 4 hours
Total urine production 5 hours
Volume of urine produced at at 5 hours after starting fasting
Measured: 5 hours
Total urine production 6 hours
Volume of urine produced at at 6 hours after starting fasting
Measured: 6 hours
Total urine production 7 hours
Volume of urine produced at at 7 hours after starting fasting
Measured: 7 hours
Body weight baseline
Body weight at baseline before fasting
Measured: 0 hours
Body weight 1 hour
Body weight at 1 hour after starting fasting
Measured: 1 hour
Body weight 2 hours
Body weight at 2 hours after starting fasting
Measured: 2 hours
Body weight 3 hours
Body weight at 3 hours after starting fasting
Measured: 3 hours
Body weight 4 hours
Body weight at 4 hours after starting fasting
Measured: 4 hours
Body weight 5 hours
Body weight at 5 hours after starting fasting
Measured: 5 hours
Body weight 6 hours
Body weight at 6 hours after starting fasting
Measured: 6 hours
Body weight 7 hours
Body weight at 7 hours after starting fasting
Measured: 7 hours
Urinary sodium baseline
Urinary sodium at baseline before starting fasting
Measured: 0 hours
Urinary sodium 1 hour
Urinary sodium at 1 hour after starting fasting
Measured: 1 hour
Urinary sodium 2 hours
Urinary sodium at 2 hours after starting fasting
Measured: 2 hours
Urinary sodium 3 hours
Urinary sodium at 3 hours after starting fasting
Measured: 3 hours
Urinary sodium 4 hours
Urinary sodium at 4 hours after starting fasting
Measured: 4 hours
Urinary sodium 5 hours
Urinary sodium at 5 hours after starting fasting
Measured: 5 hours
Urinary sodium 6 hours
Urinary sodium at 6 hours after starting fasting
Measured: 6 hours
Urinary sodium 7 hours
Urinary sodium at 7 hours after starting fasting
Measured: 7 hours
Urinary potassium baseline
Urinary potassium at baseline before starting fasting
Measured: 0 hours
Urinary potassium 1 hour
Urinary potassium at 1 hour after starting fasting
Measured: 1 hour
Urinary potassium 2 hours
Urinary potassium at 2 hours after starting fasting
Measured: 2 hours
Urinary potassium 3 hours
Urinary potassium at 3 hours after starting fasting
Measured: 3 hours
Urinary potassium 4 hours
Urinary potassium at 4 hours after starting fasting
Measured: 4 hours
Urinary potassium 5 hours
Urinary potassium at 5 hours after starting fasting
Measured: 5 hours
Urinary potassium 6 hours
Urinary potassium at 6 hours after starting fasting
Measured: 6 hours
Urinary potassium 7 hours
Urinary potassium at 7 hours after starting fasting
Measured: 7 hours
Urine colour baseline
Urine colour at baseline before starting fasting
Measured: 0 hours
Urine colour 1 hour
Urine colour at 1 hour after starting fasting
Measured: 1 hour
Urine colour 2 hours
Urine colour at 2 hours after starting fasting
Measured: 2 hours
Urine colour 3 hours
Urine colour at 3 hours after starting fasting
Measured: 3 hours
Urine colour 4 hours
Urine colour at 4 hours after starting fasting
Measured: 4 hours
Urine colour 5 hours
Urine colour at 5 hours after starting fasting
Measured: 5 hours
Urine colour 6 hours
Urine colour at 6 hours after starting fasting
Measured: 6 hours
Urine colour 7 hours
Urine colour at 7 hours after starting fasting
Measured: 7 hours
Urine specific gravity baseline
Urine specific gravity at baseline before starting fasting
Measured: 0 hours
Urine specific gravity 1 hour
Urine specific gravity at 1 hour after starting fasting
Measured: 1 hour
Urine specific gravity 2 hours
Urine specific gravity at 2 hours after starting fasting
Measured: 2 hours
Urine specific gravity 3 hours
Urine specific gravity at 3 hours after starting fasting
Measured: 3 hours
Urine specific gravity 4 hours
Urine specific gravity at 4 hours after starting fasting
Measured: 4 hours
Urine specific gravity 5 hours
Urine specific gravity at 5 hours after starting fasting
Measured: 5 hours
Urine specific gravity 6 hours
Urine specific gravity at 6 hours after starting fasting
Measured: 6 hours
Urine specific gravity 7 hours
Urine specific gravity at 7 hours after starting fasting
Measured: 7 hours
Secondary outcomes (24)
Gastrointestinal discomfort baseline
Gastrointestinal discomfort at baseline before starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 0 hours
Gastrointestinal discomfort 1 hour
Gastrointestinal discomfort at 1 hour after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 1 hour
Gastrointestinal discomfort 2 hours
Gastrointestinal discomfort at 2 hours after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 2 hours
Gastrointestinal discomfort 3 hours
Gastrointestinal discomfort at 3 hours after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 3 hours
Gastrointestinal discomfort 4 hours
Gastrointestinal discomfort at 4 hours after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 4 hours
Gastrointestinal discomfort 5 hours
Gastrointestinal discomfort at 5 hours after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 5 hours
Gastrointestinal discomfort 6 hours
Gastrointestinal discomfort at 6 hours after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 6 hours
Gastrointestinal discomfort 7 hours
Gastrointestinal discomfort at 7 hours after starting fasting using a Gastrointestinal Symptoms Questionnaire to measure 1.Abdominal pain 2.Epigastric pain (pain or discomfort right below your ribs in the area of your upper abdomen) 3. Heartburn 4. Regurgitation 5. Abdominal rumbling 6. Bloating 7. Empty feeling 8. Nausea 9. Vomiting 10. Loss of appetite 11. Postprandial fullness (an unpleasant sensation like prolonged persistence of food in the stomach) 12. belching (otherwise known as burping or eructation) 13. Flatulence (buildup of gas in the digestive system that can lead to abdominal discomfort) on a 7 point scale labelled 0 for none, 1 for mild, 2 for moderate, 3 for quite a lot, 4 for severe, 5 for very severe, 6 for unbearable. Higher scores mean worst outcome.
Measured: 7 hours
Blood Pressure baseline
Systolic and Diastolic Blood Pressure at baseline before starting fasting
Measured: 0 hours
Blood Pressure 1 hour
Systolic and Diastolic Blood Pressure at 1 hour after starting fasting
Measured: 1 hour
Blood Pressure 2 hours
Systolic and Diastolic Blood Pressure at 2 hours after starting fasting
Measured: 2 hours
Blood Pressure 3 hours
Systolic and Diastolic Blood Pressure at 3 hours after starting fasting
Measured: 3 hours
Blood Pressure 4 hours
Systolic and Diastolic Blood Pressure at 4 hours after starting fasting
Measured: 4 hours
Blood Pressure 5 hours
Systolic and Diastolic Blood Pressure at 5 hours after starting fasting
Measured: 5 hours
Blood Pressure 6 hours
Systolic and Diastolic Blood Pressure at 6 hours after starting fasting
Measured: 6 hours
Blood Pressure 7 hours
Systolic and Diastolic Blood Pressure at 7 hours after starting fasting
Measured: 7 hours
Perception of thirst at baseline
Perception of thirst at baseline before starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 0 hours
Perception of thirst at 1 hour
Perception of thirst at 1 hour after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 1 hour
Perception of thirst at 2 hours
Perception of thirst at 2 hours after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 2 hours
Perception of thirst at 3 hours
Perception of thirst at 3 hours after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 3 hours
Perception of thirst at 4 hours
Perception of thirst at 4 hours after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 4 hours
Perception of thirst at 5 hours
Perception of thirst at 5 hours after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 5 hours
Perception of thirst at 6 hours
Perception of thirst at 6 hours after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 6 hours
Perception of thirst at 7 hours
Perception of thirst at 7 hours after starting fasting using a 7 point scale labelled as 1=not thirsty at all, 2=not thirsty, 3=not very thirsty, 4=neutral, 5=thirsty, 6=very thirsty and 7=very, very thirsty.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start14 Feb 2023
- Primary completion31 May 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sangeetha Thondre, Oxford Brookes University
- Investigators
- Sangeetha Thondre, PhD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839860
- Sponsor's protocol ID
- UREC 221630
- Status last verified
- Sep 2023
- First submitted
- 23 Mar 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goulet EDB, De La Flore A, Savoie FA, Gosselin J. Salt + Glycerol-Induced Hyperhydration Enhances Fluid Retention More Than Salt- or Glycerol-Induced Hyperhydration. Int J Sport Nutr Exerc Metab. 2018 May 1;28(3):246-252. doi: 10.1123/ijsnem.2017-0310. Epub 2018 May 17.
PubMed 29140136Zanetti D, Bergman H, Burgess S, Assimes TL, Bhalla V, Ingelsson E. Urinary Albumin, Sodium, and Potassium and Cardiovascular Outcomes in the UK Biobank: Observational and Mendelian Randomization Analyses. Hypertension. 2020 Mar;75(3):714-722. doi: 10.1161/HYPERTENSIONAHA.119.14028. Epub 2020 Feb 3.
PubMed 32008434
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low and High Salt Intake on Hydration Status and Gastrointestinal Discomfort During Seven Hours of Dry Fasting
- ClinicalTrials.gov ID
- NCT05839860
- Acronym / sponsor ID
- UREC 221630
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 May 2023 (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.
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.
Detailed description
Dry fasting has been reported to cause changes in body weight, lipid profile, blood pressure, glucose level, metabolism, hormones homeostasis, and hydration status. A scoping review by the investigators highlighted that dehydration had been linked to changes in plasma volume and osmolality (concentration of all chemical particles), urine volume and osmolality, blood pressure, glucocorticoid hormones, body weight loss, negative impact on mood, irritability, short-term memory, and work productivity. It has been reported that prolonged dry fasting can contribute to a loss of up to 1.5 kg in body weight on the day after fasting. This weight loss is associated with loss of body water.
Hyperhydration (overhydration) has not yet been defined. However, any improvement in the fluid matrix in the plasma volume is considered hyperhydration. Simulating hyperhydration strategies, such as those used by athletes competing in long-distance events and in hot environments, has the potential to reduce the level of dehydration during dry fasting.
Sodium and water intake have essential roles in maintaining and improving the fluid matrix in plasma. By investigating the relationship between sodium and water intake on biomarkers such as urine sodium concentration, blood pressure, speed of urine production, urine colour, urine specific gravity, and net body fluid balance, it is possible to distinguish the impact of hyperhydration protocols on hydration levels.
The primary aim of this study is to examine the impact of salt intake (6 \& 9 g/l) on the level of hydration by measuring urine sodium, urine potassium, urine production, and changes in body weight compared to the control group during 8 hours of dry fasting. The secondary outcome of this study will be the impact of the hyperhydration protocol on GI discomfort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 g salt | Placebo comparator | Other: Salt 3 gTomatoes with 3 g salt |
| 6 g salt | Experimental | Other: Salt 6 gTomatoes with 6 g salt and 1 L of water |
| 9 g salt | Experimental | Other: Salt 9 gTomatoes with 9 g salt and 1 L of water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Salt 3 gPlacebo group taking a breakfast meal and 3g salt on tomatoes before fasting for 7 hours | Other | 3 g salt |
| Salt 6 gIntervention group taking a breakfast meal and 6g salt on tomatoes plus 1 L water before fasting for 7 hours | Other | 6 g salt |
| Salt 9 gIntervention group taking a breakfast meal and 9g salt on tomatoes plus 1 L water before fasting for 7 hours | Other | 9 g salt |
Primary outcome
Total urine production baseline
Time frame: 0 hour
Volume of urine produced at baseline
Total urine production 1 hour
Time frame: 1 hour
Volume of urine produced at 1 hour after starting fasting
Total urine production 2 hours
Time frame: 2 hours
Volume of urine produced at at 2 hours after starting fasting
Total urine production 3 hours
Time frame: 3 hours
Volume of urine produced at at 3 hours after starting fasting
Total urine production 4 hours
Time frame: 4 hours
Volume of urine produced at at 4 hours after starting fasting
Total urine production 5 hours
Time frame: 5 hours
Volume of urine produced at at 5 hours after starting fasting
Total urine production 6 hours
Time frame: 6 hours
Volume of urine produced at at 6 hours after starting fasting
Total urine production 7 hours
Time frame: 7 hours
Volume of urine produced at at 7 hours after starting fasting
Body weight baseline
Time frame: 0 hours
Body weight at baseline before fasting
Body weight 1 hour
Time frame: 1 hour
Body weight at 1 hour after starting fasting
Body weight 2 hours
Time frame: 2 hours
Body weight at 2 hours after starting fasting
Body weight 3 hours
Time frame: 3 hours
Body weight at 3 hours after starting fasting
Body weight 4 hours
Time frame: 4 hours
Body weight at 4 hours after starting fasting
Body weight 5 hours
Time frame: 5 hours
Body weight at 5 hours after starting fasting
Body weight 6 hours
Time frame: 6 hours
Body weight at 6 hours after starting fasting
Body weight 7 hours
Time frame: 7 hours
Body weight at 7 hours after starting fasting
Urinary sodium baseline
Time frame: 0 hours
Urinary sodium at baseline before starting fasting
Urinary sodium 1 hour
Time frame: 1 hour
Urinary sodium at 1 hour after starting fasting
Urinary sodium 2 hours
Time frame: 2 hours
Urinary sodium at 2 hours after starting fasting
Urinary sodium 3 hours
Time frame: 3 hours
Urinary sodium at 3 hours after starting fasting
Urinary sodium 4 hours
Time frame: 4 hours
Urinary sodium at 4 hours after starting fasting
Urinary sodium 5 hours
Time frame: 5 hours
Urinary sodium at 5 hours after starting fasting
Urinary sodium 6 hours
Time frame: 6 hours
Urinary sodium at 6 hours after starting fasting
Urinary sodium 7 hours
Time frame: 7 hours
Urinary sodium at 7 hours after starting fasting
Urinary potassium baseline
Time frame: 0 hours
Urinary potassium at baseline before starting fasting
Urinary potassium 1 hour
Time frame: 1 hour
Urinary potassium at 1 hour after starting fasting
Urinary potassium 2 hours
Time frame: 2 hours
Urinary potassium at 2 hours after starting fasting
Urinary potassium 3 hours
Time frame: 3 hours
Urinary potassium at 3 hours after starting fasting
Urinary potassium 4 hours
Time frame: 4 hours
Urinary potassium at 4 hours after starting fasting
Urinary potassium 5 hours
Time frame: 5 hours
Urinary potassium at 5 hours after starting fasting
Urinary potassium 6 hours
Time frame: 6 hours
Urinary potassium at 6 hours after starting fasting
Urinary potassium 7 hours
Time frame: 7 hours
Urinary potassium at 7 hours after starting fasting
Urine colour baseline
Time frame: 0 hours
Urine colour at baseline before starting fasting
Urine colour 1 hour
Time frame: 1 hour
Urine colour at 1 hour after starting fasting
Urine colour 2 hours
Time frame: 2 hours
Urine colour at 2 hours after starting fasting
Urine colour 3 hours
Time frame: 3 hours
Urine colour at 3 hours after starting fasting
Urine colour 4 hours
Time frame: 4 hours
Urine colour at 4 hours after starting fasting
Urine colour 5 hours
Time frame: 5 hours
Urine colour at 5 hours after starting fasting
Urine colour 6 hours
Time frame: 6 hours
Urine colour at 6 hours after starting fasting
Urine colour 7 hours
Time frame: 7 hours
Urine colour at 7 hours after starting fasting
Urine specific gravity baseline
Time frame: 0 hours
Urine specific gravity at baseline before starting fasting
Urine specific gravity 1 hour
Time frame: 1 hour
Urine specific gravity at 1 hour after starting fasting
Urine specific gravity 2 hours
Time frame: 2 hours
Urine specific gravity at 2 hours after starting fasting
Urine specific gravity 3 hours
Time frame: 3 hours
Urine specific gravity at 3 hours after starting fasting
Urine specific gravity 4 hours
Time frame: 4 hours
Urine specific gravity at 4 hours after starting fasting
Urine specific gravity 5 hours
Time frame: 5 hours
Urine specific gravity at 5 hours after starting fasting
Urine specific gravity 6 hours
Time frame: 6 hours
Urine specific gravity at 6 hours after starting fasting
Urine specific gravity 7 hours
Time frame: 7 hours
Urine specific gravity at 7 hours after starting fasting
24 secondary outcomes
Gastrointestinal discomfort baseline
Time frame: 0 hours
Gastrointestinal discomfort 1 hour
Time frame: 1 hour
Gastrointestinal discomfort 2 hours
Time frame: 2 hours
Gastrointestinal discomfort 3 hours
Time frame: 3 hours
Gastrointestinal discomfort 4 hours
Time frame: 4 hours
Gastrointestinal discomfort 5 hours
Time frame: 5 hours
Gastrointestinal discomfort 6 hours
Time frame: 6 hours
Gastrointestinal discomfort 7 hours
Time frame: 7 hours
Blood Pressure baseline
Time frame: 0 hours
Blood Pressure 1 hour
Time frame: 1 hour
Blood Pressure 2 hours
Time frame: 2 hours
Blood Pressure 3 hours
Time frame: 3 hours
Blood Pressure 4 hours
Time frame: 4 hours
Blood Pressure 5 hours
Time frame: 5 hours
Blood Pressure 6 hours
Time frame: 6 hours
Blood Pressure 7 hours
Time frame: 7 hours
Perception of thirst at baseline
Time frame: 0 hours
Perception of thirst at 1 hour
Time frame: 1 hour
Perception of thirst at 2 hours
Time frame: 2 hours
Perception of thirst at 3 hours
Time frame: 3 hours
Perception of thirst at 4 hours
Time frame: 4 hours
Perception of thirst at 5 hours
Time frame: 5 hours
Perception of thirst at 6 hours
Time frame: 6 hours
Perception of thirst at 7 hours
Time frame: 7 hours
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 6 Sep 2023.
- Background: PubMed 29140136Goulet EDB, De La Flore A, Savoie FA, Gosselin J. Salt + Glycerol-Induced Hyperhydration Enhances Fluid Retention More Than Salt- or Glycerol-Induced Hyperhydration. Int J Sport Nutr Exerc Metab. 2018 May 1;28(3):246-252. doi: 10.1123/ijsnem.2017-0310. Epub 2018 May 17.
- Background: PubMed 32008434Zanetti D, Bergman H, Burgess S, Assimes TL, Bhalla V, Ingelsson E. Urinary Albumin, Sodium, and Potassium and Cardiovascular Outcomes in the UK Biobank: Observational and Mendelian Randomization Analyses. Hypertension. 2020 Mar;75(3):714-722. doi: 10.1161/HYPERTENSIONAHA.119.14028. Epub 2020 Feb 3.
- 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.
Sangeetha Thondre, PhD principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt 3 g, Salt 6 g and Salt 9 g in people with Healthy, run by Oxford Brookes University at 1 site in United Kingdom.
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 9 inclusion and 9 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 6 Sep 2023. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Total urine production baseline (time frame: 0 hour). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839860, which also lists 2 linked publications.
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 6 Sep 2023.