## Protocol Section
### Identification Module
**NCT ID:** NCT06414291

**Acronym:** LIV-D2O

**Brief Title:** Rehydration Efficiency During Ad-libitum Fluid Intake

**Official Title:** Rehydration Efficiency During Ad-libitum Fluid Intake

#### Organization Study ID Info
**ID:** FP00039672
#### Organization
**Class:** OTHER
**Full Name:** Arizona State University
### Status Module
#### Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Arizona State University

#### Responsible Party

**Investigator Affiliation:** Arizona State University

**Investigator Full Name:** Stavros Kavouras

**Investigator Title:** Professor & Assistant Dean

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** It is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. This is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. Also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. As a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin.

The present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration.

### Conditions Module

**Conditions:**

- Dehydration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Masking Description:** non labeled bottles

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Rehydration with low mineral content bottle water

**Intervention Names:**

- Other: Plain Water

**Label:** Water

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV

**Intervention Names:**

- Other: Liquid IV Hydration Multiplier

**Label:** Carbohydrate Electrolyte solution

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

**Intervention Names:**

- Other: Liquid IV Sugar Free

**Label:** Low Sugar electrolyte solution

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Water

**Description:** Plain water without calories, sweetener, or electolytes

**Name:** Plain Water

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Carbohydrate Electrolyte solution

**Description:** Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV

**Name:** Liquid IV Hydration Multiplier

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Low Sugar electrolyte solution

**Description:** 10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

**Name:** Liquid IV Sugar Free

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Total amount of fluid ingested

**Measure:** Total fluid intake

**Time Frame:** 4 hours of rehydration

**Description:** amount of water retained during the rehydration period

**Measure:** Net fluid balance

**Time Frame:** at 4 hours of the rehydration period

**Description:** amount of water retained during the rehydration period

**Measure:** Net fluid balance

**Time Frame:** at 3 hours of the rehydration period

**Description:** The rate of Deuterium appearance in the blood during 30 minutes of rehydration

**Measure:** Rate of absorption

**Time Frame:** during the first 30 minutes of rehydration

**Description:** The rate of Deuterium appearance in the blood during 60 minutes of rehydration

**Measure:** Rate of absorption

**Time Frame:** during the first 60 minutes of rehydration

**Description:** The rate of Deuterium appearance in the blood during 120 minutes of rehydration

**Measure:** Rate of absorption

**Time Frame:** during the first 120 minutes of rehydration

**Description:** The rate of Deuterium appearance in the blood during 180 minutes of rehydration

**Measure:** Rate of absorption

**Time Frame:** during the first 180 minutes of rehydration

**Description:** The rate of Deuterium appearance in the blood during 240 minutes of rehydration

**Measure:** Rate of absorption

**Time Frame:** during the first 240 minutes of rehydration

**Description:** Total amount of urine output during rehydration

**Measure:** Cumulative urine output

**Time Frame:** during the first 3 hours of rehydration

**Description:** Total amount of urine output during rehydration

**Measure:** Cumulative urine output

**Time Frame:** during the first 4 hours of rehydration

#### Secondary Outcomes

**Description:** Plasam Copeptin during rehydration

**Measure:** Plasma copeptin

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

**Description:** percent of plasma volume recovery during the rehydration

**Measure:** Plasma volume

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

**Description:** Free water clearance calculated based on plasma and urine osmolality

**Measure:** Free water Clearance

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

**Description:** Free Osmotic clearance calculated based on plasma and urine osmolality

**Measure:** Free Osmotic Clearance

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

**Description:** Thirst estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception

**Measure:** Thirst

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

**Description:** Stomach fullness estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception

**Measure:** Stomach fullness

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

**Description:** Taste Likeness estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception

**Measure:** Taste Likeness

**Time Frame:** at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18-60 years
* Training at least 2 times per week
* stable weight for the last 2 months (fluctuation less than 5 pounds)

Exclusion Criteria:

* Night shifting work
* Thyroid medication
* Bariatric surgery
* Cardiovascular disease
* Renal disease
* Hepatic disease
* Participating in another study at the same time
* Bodyweight over 110 pounds

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stavros.kavouras@asu.edu

**Name:** Stavros Kavouras, PhD

**Phone:** (602) 496-2547

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Interdisciplinary Science and Technology Building 8

**State:** Arizona

**Zip:** 85004

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014883

- Term: Water-Electrolyte Imbalance

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6883

- Name: Dehydration

- Relevance: HIGH

- As Found: Dehydration

- ID: M17624

- Name: Water-Electrolyte Imbalance

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003681

- Term: Dehydration

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
