The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-07-25

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Low Water Intake High Vasopressin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Water intervention

The participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks.

Group Type EXPERIMENTAL

Water

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Water

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes