NCT05839860

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

March 23, 2023

Last Update Submit

September 4, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (48)

  • 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 Outcomes (24)

  • Gastrointestinal discomfort baseline

    0 hours

  • Gastrointestinal discomfort 1 hour

    1 hour

  • Gastrointestinal discomfort 2 hours

    2 hours

  • Gastrointestinal discomfort 3 hours

    3 hours

  • Gastrointestinal discomfort 4 hours

    4 hours

  • +19 more secondary outcomes

Study Arms (3)

3 g salt

PLACEBO COMPARATOR

Tomatoes with 3 g salt

Other: Salt 3 g

6 g salt

EXPERIMENTAL

Tomatoes with 6 g salt and 1 L of water

Other: Salt 6 g

9 g salt

EXPERIMENTAL

Tomatoes with 9 g salt and 1 L of water

Other: Salt 9 g

Interventions

Salt 3 gOTHER

Placebo group taking a breakfast meal and 3g salt on tomatoes before fasting for 7 hours

3 g salt
Salt 6 gOTHER

Intervention group taking a breakfast meal and 6g salt on tomatoes plus 1 L water before fasting for 7 hours

6 g salt
Salt 9 gOTHER

Intervention group taking a breakfast meal and 9g salt on tomatoes plus 1 L water before fasting for 7 hours

9 g salt

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Brookes Centre for Nutrition and Health

Oxford, OX3 0BP, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 29140136BACKGROUND

  • 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.

    PMID: 32008434BACKGROUND

MeSH Terms

Interventions

Salts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Sangeetha Thondre, PhD

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

March 23, 2023

First Posted

May 3, 2023

Study Start

February 14, 2023

Primary Completion

May 31, 2023

Study Completion

July 31, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)