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The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03574688
Acronym
H2OMetaboPilot
Enrollment
34
Registered
2018-07-02
Start date
2017-02-02
Completion date
2017-07-25
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Vasopressin, Low Water Intake

Keywords

Hydration, Water, Vasopressin, Copeptin, Glucose

Brief summary

This study evaluates increased hydration (1.5 L of water daily during 6 weeks) on top of habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering of plasma glucose concentration in adults with signs of low water intake at recruitment (elevated levels of copeptin, high urine osmolality, low urine volume).

Detailed description

High plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. The main physiological role of vasopressin is to maintain constant plasma osmolality. Previous studies in rats and a Mendelian randomization study in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, the investigators hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes. The aim of this pilot study is to test if six weeks of water supplementation of 1.5 Liters of extra water per day in low-drinkers with high copeptin can significantly alter hydration markers in general and reduce plasma copeptin in particular. Furthermore, the investigators also aim at investigating whether this 6-week water intervention can significantly reduce fasting plasma glucose concentration.

Interventions

DIETARY_SUPPLEMENTWater

Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake.

Sponsors

Lund University
CollaboratorOTHER
Danone Global Research & Innovation Center
CollaboratorINDUSTRY
Region Skane
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Provision of informed consent * Age 20-75 years * High plasma concentration of copeptin of \>6.1 pmol/L in women and \> 10.7 pmol/L in men * 24-hour urine osmolality \> 600 milliosmol (mosm) /kg water.

Exclusion criteria

* 24-hour urine volume \>1.5 L * Pregnancy or breastfeeding * Plasma sodium \<135 mmol/L * Use of diuretics, lithium or SSRI drugs * Chronic kidney disease (estimated glomerular filtration rate \< 30mL/min) * Heart failure * Inflammatory bowel disease * Type 1 diabetes or type 2 diabetes treated with insulin * Vulnerable subjects (subjects with legal guardian, with loss of personal liberty)

Design outcomes

Primary

MeasureTime frameDescription
Fasting plasma copeptin concentration (pmol/L)6 weeksChange of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.

Secondary

MeasureTime frameDescription
24 hour urine osmolality (mosm/kg H2O)6 weeksChange of 24 hour urine osmolality between baseline and after 6 weeks of increased water intake.
24 hour urine volume (L/24h)6 weeksChange of 24 hour urine volume between baseline and after 6 weeks of increased water intake.
Drinking water (L/day)6 weeksChange of intake of tap and bottled water between baseline and after 6 weeks of increased water intake.
Total water (L/day)6 weeksChange of total water intake between baseline and after 6 weeks of increased water intake.
Fasting plasma glucose concentration (mmol/L)6 weeksChange of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026