- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05839860
Salt Intake, Hydration Status and Gastrointestinal Discomfort During Fasting
The Effect of Low and High Salt Intake on Hydration Status and Gastrointestinal Discomfort During Seven Hours of Dry Fasting
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oxford, United Kingdom, OX3 0BP
- Oxford Brookes Centre for Nutrition and Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3 g salt
Tomatoes with 3 g salt
|
Placebo group taking a breakfast meal and 3g salt on tomatoes before fasting for 7 hours
|
Experimental: 6 g salt
Tomatoes with 6 g salt and 1 L of water
|
Intervention group taking a breakfast meal and 6g salt on tomatoes plus 1 L water before fasting for 7 hours
|
Experimental: 9 g salt
Tomatoes with 9 g salt and 1 L of water
|
Intervention group taking a breakfast meal and 9g salt on tomatoes plus 1 L water before fasting for 7 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total urine production baseline
Time Frame: 0 hour
|
Volume of urine produced at baseline
|
0 hour
|
Total urine production 1 hour
Time Frame: 1 hour
|
Volume of urine produced at 1 hour after starting fasting
|
1 hour
|
Total urine production 2 hours
Time Frame: 2 hours
|
Volume of urine produced at at 2 hours after starting fasting
|
2 hours
|
Total urine production 3 hours
Time Frame: 3 hours
|
Volume of urine produced at at 3 hours after starting fasting
|
3 hours
|
Total urine production 4 hours
Time Frame: 4 hours
|
Volume of urine produced at at 4 hours after starting fasting
|
4 hours
|
Total urine production 5 hours
Time Frame: 5 hours
|
Volume of urine produced at at 5 hours after starting fasting
|
5 hours
|
Total urine production 6 hours
Time Frame: 6 hours
|
Volume of urine produced at at 6 hours after starting fasting
|
6 hours
|
Total urine production 7 hours
Time Frame: 7 hours
|
Volume of urine produced at at 7 hours after starting fasting
|
7 hours
|
Body weight baseline
Time Frame: 0 hours
|
Body weight at baseline before fasting
|
0 hours
|
Body weight 1 hour
Time Frame: 1 hour
|
Body weight at 1 hour after starting fasting
|
1 hour
|
Body weight 2 hours
Time Frame: 2 hours
|
Body weight at 2 hours after starting fasting
|
2 hours
|
Body weight 3 hours
Time Frame: 3 hours
|
Body weight at 3 hours after starting fasting
|
3 hours
|
Body weight 4 hours
Time Frame: 4 hours
|
Body weight at 4 hours after starting fasting
|
4 hours
|
Body weight 5 hours
Time Frame: 5 hours
|
Body weight at 5 hours after starting fasting
|
5 hours
|
Body weight 6 hours
Time Frame: 6 hours
|
Body weight at 6 hours after starting fasting
|
6 hours
|
Body weight 7 hours
Time Frame: 7 hours
|
Body weight at 7 hours after starting fasting
|
7 hours
|
Urinary sodium baseline
Time Frame: 0 hours
|
Urinary sodium at baseline before starting fasting
|
0 hours
|
Urinary sodium 1 hour
Time Frame: 1 hour
|
Urinary sodium at 1 hour after starting fasting
|
1 hour
|
Urinary sodium 2 hours
Time Frame: 2 hours
|
Urinary sodium at 2 hours after starting fasting
|
2 hours
|
Urinary sodium 3 hours
Time Frame: 3 hours
|
Urinary sodium at 3 hours after starting fasting
|
3 hours
|
Urinary sodium 4 hours
Time Frame: 4 hours
|
Urinary sodium at 4 hours after starting fasting
|
4 hours
|
Urinary sodium 5 hours
Time Frame: 5 hours
|
Urinary sodium at 5 hours after starting fasting
|
5 hours
|
Urinary sodium 6 hours
Time Frame: 6 hours
|
Urinary sodium at 6 hours after starting fasting
|
6 hours
|
Urinary sodium 7 hours
Time Frame: 7 hours
|
Urinary sodium at 7 hours after starting fasting
|
7 hours
|
Urinary potassium baseline
Time Frame: 0 hours
|
Urinary potassium at baseline before starting fasting
|
0 hours
|
Urinary potassium 1 hour
Time Frame: 1 hour
|
Urinary potassium at 1 hour after starting fasting
|
1 hour
|
Urinary potassium 2 hours
Time Frame: 2 hours
|
Urinary potassium at 2 hours after starting fasting
|
2 hours
|
Urinary potassium 3 hours
Time Frame: 3 hours
|
Urinary potassium at 3 hours after starting fasting
|
3 hours
|
Urinary potassium 4 hours
Time Frame: 4 hours
|
Urinary potassium at 4 hours after starting fasting
|
4 hours
|
Urinary potassium 5 hours
Time Frame: 5 hours
|
Urinary potassium at 5 hours after starting fasting
|
5 hours
|
Urinary potassium 6 hours
Time Frame: 6 hours
|
Urinary potassium at 6 hours after starting fasting
|
6 hours
|
Urinary potassium 7 hours
Time Frame: 7 hours
|
Urinary potassium at 7 hours after starting fasting
|
7 hours
|
Urine colour baseline
Time Frame: 0 hours
|
Urine colour at baseline before starting fasting
|
0 hours
|
Urine colour 1 hour
Time Frame: 1 hour
|
Urine colour at 1 hour after starting fasting
|
1 hour
|
Urine colour 2 hours
Time Frame: 2 hours
|
Urine colour at 2 hours after starting fasting
|
2 hours
|
Urine colour 3 hours
Time Frame: 3 hours
|
Urine colour at 3 hours after starting fasting
|
3 hours
|
Urine colour 4 hours
Time Frame: 4 hours
|
Urine colour at 4 hours after starting fasting
|
4 hours
|
Urine colour 5 hours
Time Frame: 5 hours
|
Urine colour at 5 hours after starting fasting
|
5 hours
|
Urine colour 6 hours
Time Frame: 6 hours
|
Urine colour at 6 hours after starting fasting
|
6 hours
|
Urine colour 7 hours
Time Frame: 7 hours
|
Urine colour at 7 hours after starting fasting
|
7 hours
|
Urine specific gravity baseline
Time Frame: 0 hours
|
Urine specific gravity at baseline before starting fasting
|
0 hours
|
Urine specific gravity 1 hour
Time Frame: 1 hour
|
Urine specific gravity at 1 hour after starting fasting
|
1 hour
|
Urine specific gravity 2 hours
Time Frame: 2 hours
|
Urine specific gravity at 2 hours after starting fasting
|
2 hours
|
Urine specific gravity 3 hours
Time Frame: 3 hours
|
Urine specific gravity at 3 hours after starting fasting
|
3 hours
|
Urine specific gravity 4 hours
Time Frame: 4 hours
|
Urine specific gravity at 4 hours after starting fasting
|
4 hours
|
Urine specific gravity 5 hours
Time Frame: 5 hours
|
Urine specific gravity at 5 hours after starting fasting
|
5 hours
|
Urine specific gravity 6 hours
Time Frame: 6 hours
|
Urine specific gravity at 6 hours after starting fasting
|
6 hours
|
Urine specific gravity 7 hours
Time Frame: 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
Time Frame: 0 hours
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 0 hours
|
Systolic and Diastolic Blood Pressure at baseline before starting fasting
|
0 hours
|
Blood Pressure 1 hour
Time Frame: 1 hour
|
Systolic and Diastolic Blood Pressure at 1 hour after starting fasting
|
1 hour
|
Blood Pressure 2 hours
Time Frame: 2 hours
|
Systolic and Diastolic Blood Pressure at 2 hours after starting fasting
|
2 hours
|
Blood Pressure 3 hours
Time Frame: 3 hours
|
Systolic and Diastolic Blood Pressure at 3 hours after starting fasting
|
3 hours
|
Blood Pressure 4 hours
Time Frame: 4 hours
|
Systolic and Diastolic Blood Pressure at 4 hours after starting fasting
|
4 hours
|
Blood Pressure 5 hours
Time Frame: 5 hours
|
Systolic and Diastolic Blood Pressure at 5 hours after starting fasting
|
5 hours
|
Blood Pressure 6 hours
Time Frame: 6 hours
|
Systolic and Diastolic Blood Pressure at 6 hours after starting fasting
|
6 hours
|
Blood Pressure 7 hours
Time Frame: 7 hours
|
Systolic and Diastolic Blood Pressure at 7 hours after starting fasting
|
7 hours
|
Perception of thirst at baseline
Time Frame: 0 hours
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sangeetha Thondre, PhD, Oxford Brookes University
Publications and helpful links
General 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.
- Zanetti 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UREC 221630
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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