NCT07028021

Brief Summary

Water is essential for sustaining life and maintaining health. The human body relies on water to transport nutrients and waste products, lubricate joints, regulate body temperature, and preserve tissue structure. International research has shown that losing just 2% of body weight through water loss can impair physiological functions and reduce response capacity. Adequate water intake plays a crucial protective role in health: it helps regulate body weight, lowers the risk of chronic diseases such as cardiovascular and cerebrovascular conditions, and supports cognitive function. However, the common recommendation to drink eight cups of water per day lacks strong scientific evidence. Most national hydration guidelines are based on average population intake, and personalized water intake recommendations have yet to be fully developed. In this study, the investigators will use the deuterium dilution technique to measure water turnover in volunteers. Body composition will be assessed using the TANITA MC-780, while a seven-day fluid intake diary will track daily water consumption. Physical activity levels will be monitored using GT3 devices, and environmental data-including altitude, temperature, and humidity-will be collected based on participants' locations. The goal of this study is to collect comprehensive data on the physiological traits, environmental influences, and hydration needs of the Chinese population. This will allow for refinement and optimization of current prediction equations for water requirements. Ultimately, the investigators aim to develop a new, individualized water intake algorithm tailored to the Chinese population by quantifying the proportion of water intake relative to total water requirements.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
May 2025Oct 2026

Study Start

First participant enrolled

May 6, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 3, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Height

    Height in meters (m) will be measured using the SECA 217 stable stadiometer. Subjects will be measured without shoes.

    Height measurement will be conducted on the first day of the study for each volunteer and will take approximately 2 minutes.

  • Body weight

    Body weight in kilograms (kg) will be measured using the TANITA MC-780 device. Participants will be barefoot and dressed in light clothing during the measurement.

    Body weight will be conducted on the first day of the study for each volunteer and will take approximately 5 minutes.

  • Body composition

    The TANITA (TANITA MC-780) device will be used to measure fat mass (in kilograms, kg) as a primary indicator of body composition. Participants will be asked to remove all metal accessories and wear light clothing during the measurement.

    Body composition ( fat mass )will be conducted on the first day of the study for each volunteer and will take approximately 5 minutes.

  • Body water

    Body water in kilograms will be measured by deuterium dilution. Subjects will attend the lab after an overnight fast and provide a baseline urine sample. They will then drink a dose of deuterated water based on their body weight. Urine samples will be collected at 4 hours after dosing, and 7 days after dosing, to measure the level of deuterium isotope in the body relative to the baseline. The increase in deuterium concentration allows for the calculation of total body water based on the dilution principle.

    Deuterium dilution technology will be initiated at the start of the volunteer's research visit, with each volunteer undergoing a one-week data collection period .

  • Physical Activity

    Physical activity (in vector magnitude counts) of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 7 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days.

    Physical activity will be initiated at the start of the volunteer's research visit, with each volunteer undergoing a one-week data collection period.,and will be used in subsequent data analyses.

  • Water Intake Measurement

    Water intake will be recorded using a seven-day liquid intake diary. A standardized form will be provided to the volunteers, where they will record the type, time, and amount (in milliliters, mL) of liquid consumed across approximately four specific time periods each day. Detailed recording standards and instructions will be included in the form.

    Water intake will be initiated at the start of the volunteer's research visit, with each volunteer undergoing a one-week data collection period, and will be used in subsequent data analyses.

  • Environmental temperature

    The iButton (DS1921G) will be used to assess the subject's exposure to temperature (in Degrees Celsius) by measuring both indoor and outdoor temperatures. The devices will be placed on the subject's hand bag or clothes, the indoor wall of the home and workplace, and the exterior building surface.

    Environmental temperature exposure will be monitored for one week beginning at the start of the volunteer's research visit

  • Average residential altitude of participant

    The average altitude (in meters) of the participant's residential city will be determined using GPS-based altitude software.

    The average altitude will be recorded at the start of the volunteer's participation in the study and will take approximately 2 minutes.

Study Arms (6)

Volunteers from Beijing

A total of 50 local volunteers will be recruited in Beijing to participate in the study. The study procedures will include height measurement, body composition analysis, body water turnover assessment, water intake documentation, physical activity level monitoring, and evaluation of environmental factors (temperature, humidity, and altitude).

Volunteers from Shenzhen

A total of 50 local volunteers will be recruited in Shenzhen to participate in the study. The study procedures will include height measurement, body composition analysis, body water turnover assessment, water intake documentation, physical activity level monitoring, and evaluation of environmental factors (temperature, humidity, and altitude).

Volunteers from Shenyang

A total of 50 local volunteers will be recruited in Shenyang to participate in the study. The study procedures will include height measurement, body composition analysis, body water turnover assessment, water intake documentation, physical activity level monitoring, and evaluation of environmental factors (temperature, humidity, and altitude).

Volunteers from Yantai

A total of 50 local volunteers will be recruited in Yantai to participate in the study. The study procedures will include height measurement, body composition analysis, body water turnover assessment, water intake documentation, physical activity level monitoring, and evaluation of environmental factors (temperature, humidity, and altitude).

Volunteers from Xining

A total of 50 local volunteers will be recruited in Xining to participate in the study. The study procedures will include height measurement, body composition analysis, body water turnover assessment, water intake documentation, physical activity level monitoring, and evaluation of environmental factors (temperature, humidity, and altitude).

Volunteers from Wenzhou

A total of 50 local volunteers will be recruited in Wenzhou to participate in the study. The study procedures will include height measurement, body composition analysis, body water turnover assessment, water intake documentation, physical activity level monitoring, and evaluation of environmental factors (temperature, humidity, and altitude).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consisted of healthy individuals with stable body weight over the past year and the ability to engage in normal physical activities. Participants had no history of chronic diseases, were not taking diuretics or other medications that affect urine output, and female participants were neither pregnant nor breastfeeding.

You may qualify if:

  • Stable body weight over the past year
  • Ability to perform normal physical activities

You may not qualify if:

  • History of chronic diseases such as diabetes, liver disease, kidney disease, or any other conditions that may affect fluid metabolism
  • Use of diuretics or other medications that influence urine output
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 19, 2025

Study Start

May 6, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations