Salt Intake, Hydration Status and Gastrointestinal Discomfort During Fasting

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Low and High Salt Intake on Hydration Status and Gastrointestinal Discomfort During Seven Hours of Dry Fasting

Conditions
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Healthy

Intervention / Treatment
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* Other: Salt 3 g
* Other: Salt 6 g
* Other: Salt 9 g


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 3 g salt<br>Tomatoes with 3 g salt | Other: Salt 3 g<br>* Placebo group taking a breakfast meal and 3g salt on tomatoes before fasting for 7 hours<br>|
| Experimental: 6 g salt<br>Tomatoes with 6 g salt and 1 L of water | Other: Salt 6 g<br>* Intervention group taking a breakfast meal and 6g salt on tomatoes plus 1 L water before fasting for 7 hours<br>|
| Experimental: 9 g salt<br>Tomatoes with 9 g salt and 1 L of water | Other: Salt 9 g<br>* Intervention group taking a breakfast meal and 9g salt on tomatoes plus 1 L water before fasting for 7 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total urine production baseline | Volume of urine produced at baseline | 0 hour | 
| Total urine production 1 hour | Volume of urine produced at 1 hour after starting fasting | 1 hour | 
| Total urine production 2 hours | Volume of urine produced at at 2 hours after starting fasting | 2 hours | 
| Total urine production 3 hours | Volume of urine produced at at 3 hours after starting fasting | 3 hours | 
| Total urine production 4 hours | Volume of urine produced at at 4 hours after starting fasting | 4 hours | 
| Total urine production 5 hours | Volume of urine produced at at 5 hours after starting fasting | 5 hours | 
| Total urine production 6 hours | Volume of urine produced at at 6 hours after starting fasting | 6 hours | 
| Total urine production 7 hours | Volume of urine produced at at 7 hours after starting fasting | 7 hours | 
| Body weight baseline | Body weight at baseline before fasting | 0 hours | 
| Body weight 1 hour | Body weight at 1 hour after starting fasting | 1 hour | 
| Body weight 2 hours | Body weight at 2 hours after starting fasting | 2 hours | 
| Body weight 3 hours | Body weight at 3 hours after starting fasting | 3 hours | 
| Body weight 4 hours | Body weight at 4 hours after starting fasting | 4 hours | 
| Body weight 5 hours | Body weight at 5 hours after starting fasting | 5 hours | 
| Body weight 6 hours | Body weight at 6 hours after starting fasting | 6 hours | 
| Body weight 7 hours | Body weight at 7 hours after starting fasting | 7 hours | 
| Urinary sodium baseline | Urinary sodium at baseline before starting fasting | 0 hours | 
| Urinary sodium 1 hour | Urinary sodium at 1 hour after starting fasting | 1 hour | 
| Urinary sodium 2 hours | Urinary sodium at 2 hours after starting fasting | 2 hours | 
| Urinary sodium 3 hours | Urinary sodium at 3 hours after starting fasting | 3 hours | 
| Urinary sodium 4 hours | Urinary sodium at 4 hours after starting fasting | 4 hours | 
| Urinary sodium 5 hours | Urinary sodium at 5 hours after starting fasting | 5 hours | 
| Urinary sodium 6 hours | Urinary sodium at 6 hours after starting fasting | 6 hours | 
| Urinary sodium 7 hours | Urinary sodium at 7 hours after starting fasting | 7 hours | 
| Urinary potassium baseline | Urinary potassium at baseline before starting fasting | 0 hours | 
| Urinary potassium 1 hour | Urinary potassium at 1 hour after starting fasting | 1 hour | 
| Urinary potassium 2 hours | Urinary potassium at 2 hours after starting fasting | 2 hours | 
| Urinary potassium 3 hours | Urinary potassium at 3 hours after starting fasting | 3 hours | 
| Urinary potassium 4 hours | Urinary potassium at 4 hours after starting fasting | 4 hours | 
| Urinary potassium 5 hours | Urinary potassium at 5 hours after starting fasting | 5 hours | 
| Urinary potassium 6 hours | Urinary potassium at 6 hours after starting fasting | 6 hours | 
| Urinary potassium 7 hours | Urinary potassium at 7 hours after starting fasting | 7 hours | 
| Urine colour baseline | Urine colour at baseline before starting fasting | 0 hours | 
| Urine colour 1 hour | Urine colour at 1 hour after starting fasting | 1 hour | 
| Urine colour 2 hours | Urine colour at 2 hours after starting fasting | 2 hours | 
| Urine colour 3 hours | Urine colour at 3 hours after starting fasting | 3 hours | 
| Urine colour 4 hours | Urine colour at 4 hours after starting fasting | 4 hours | 
| Urine colour 5 hours | Urine colour at 5 hours after starting fasting | 5 hours | 
| Urine colour 6 hours | Urine colour at 6 hours after starting fasting | 6 hours | 
| Urine colour 7 hours | Urine colour at 7 hours after starting fasting | 7 hours | 
| Urine specific gravity baseline | Urine specific gravity at baseline before starting fasting | 0 hours | 
| Urine specific gravity 1 hour | Urine specific gravity at 1 hour after starting fasting | 1 hour | 
| Urine specific gravity 2 hours | Urine specific gravity at 2 hours after starting fasting | 2 hours | 
| Urine specific gravity 3 hours | Urine specific gravity at 3 hours after starting fasting | 3 hours | 
| Urine specific gravity 4 hours | Urine specific gravity at 4 hours after starting fasting | 4 hours | 
| Urine specific gravity 5 hours | Urine specific gravity at 5 hours after starting fasting | 5 hours | 
| Urine specific gravity 6 hours | Urine specific gravity at 6 hours after starting fasting | 6 hours | 
| Urine specific gravity 7 hours | Urine specific gravity at 7 hours after starting fasting | 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 7 hours | 
| Blood Pressure baseline | Systolic and Diastolic Blood Pressure at baseline before starting fasting | 0 hours | 
| Blood Pressure 1 hour | Systolic and Diastolic Blood Pressure at 1 hour after starting fasting | 1 hour | 
| Blood Pressure 2 hours | Systolic and Diastolic Blood Pressure at 2 hours after starting fasting | 2 hours | 
| Blood Pressure 3 hours | Systolic and Diastolic Blood Pressure at 3 hours after starting fasting | 3 hours | 
| Blood Pressure 4 hours | Systolic and Diastolic Blood Pressure at 4 hours after starting fasting | 4 hours | 
| Blood Pressure 5 hours | Systolic and Diastolic Blood Pressure at 5 hours after starting fasting | 5 hours | 
| Blood Pressure 6 hours | Systolic and Diastolic Blood Pressure at 6 hours after starting fasting | 6 hours | 
| Blood Pressure 7 hours | Systolic and Diastolic Blood Pressure at 7 hours after starting fasting | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 7 hours |