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Completed

NCT Number: NCT06165185

Water and Coffee Intervention in Humans

39 healthy subjects without medication (except oral contraceptives) aged 20-70 years are recruited via advertisements or through telephone contacts with individuals that had previously participated in population-based cohort studies in Malmö. All subjects are exposed to three different intervention procedures; water and coffee loads (acutely and chronically), or no change from usual fluid intake (as a time-control), respectively in randomized order. The daily intake of coffee or water will amount to 3 L of water and 1 L of coffee, respectively for one week each. The three interventions (water, coffee and control), are separated by three weeks of normal fluid intake as a wash-out period.

By testing if simple life style interventions, i.e., increased water or coffee intake, may affect vasopressin secretion, evaluated as copeptin, we will increase the knowledge as to whether such life style induced changes of copeptin may in turn lead to effects on glucose tolerance as well as on other cardiometabolic risk factors previously shown to be associated with high copeptin level. Thus, the study will lead to further understanding about vasopressin and copeptin release and how life style manipulation of the vasopressin system may influence glucose metabolism and other cardiometabolic risk factors in healthy individuals.

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Key information

Conditions

Excess Intake of Macronutrients Diabetes Insipidus Endocrine System Diseases Excess Intake of Micronutrients Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases Vasopressin Low

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical research unit, Internal medicine department, Skåne University Hospital in Malmö

Malmö, 20502, Sweden

About this study

Day 1: The initial examination consists of medical history, clinical examination including office blood pressure, and blood sampling (overnight fasting plasma copeptin (a marker of vasopressin), osmolality, insulin, glucagon, glucose, creatinine, hsCRP and OGTT), and start of 24-h urine collection and 24-h ambulatory blood pressure measurement.

Day 2: After completion of the 24-h urine collection and ABPM, in the fasting state in the morning, office blood pressure will be measured and blood sampling for plasma copeptin, osmolality insulin, glucagon, glucose, creatinine and hsCRP measurement will be performed. Then, during a maximum time period of 20 minutes, subjects will ingest either 1L of water or 4 dL of coffee, or just 10 ml of water (time control). To map the acute coffee or water effect on copeptin, the experiment proceeds with repeated blood sampling every 30 minutes for 4 hours after the first coffee or water intake. Day 1 then continues with the rest of the daily intake, i.e., 2 L of water or 6 dL of coffee in addition to normal food and fluid intakes.

Day 3 to 7: 3 L water per day or 1 L of coffee per day are ingested (or nothing, in the control intervention) in addition to each subject's own food and fluid intake. On days 4 and 6, blood sampling for electrolyte and urea measurement and osmolality will be carried out for reasons of safety and compliance check.

Day 8: Fasting in the morning, office blood pressure, blood sampling (copeptin, osmolality, insulin, glucagon, glucose, creatinine, hsCRP) will be performed and a 24-h urine collection and ABPM will be started.

Day 9: The final examination will consist of clinical examination including office blood pressure and blood sampling (overnight fasting plasma copeptin, osmolality, insulin, glucagon, glucose, creatinine, hsCRP and OGTT), and end of 24-h urine collection and ABPM.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects Age 20-70 years

Exclusion criteria

medication (except oral contraceptives) any type of acute illness any type of chronic illness

Treatment and study plan

Water

Other

Please see the associated arm description

Coffee

Other

Please see the associated arm description

Control

Other

Please see the associated arm description

Primary outcomes

  1. 1 week result on plasma copeptin

    Time frame: 7 days

    Change ("∆-value") between plasma copeptin value (pmol/L) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

Secondary outcomes

  1. 1 week result on plasma glucose

    Time frame: 7 days

    Change ("∆-value") between plasma glucose (mmol/L) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  2. 1 week result on plasma insulin

    Time frame: 7 days

    Change ("∆-value") between plasma insulin (IE) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  3. 1 week result on plasma glucagon

    Time frame: 7 days

    Change ("∆-value") between plasma glucagon (pmol/L) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  4. 1 week result on plasma C-reactive protein

    Time frame: 7 days

    Change ("∆-value") between plasma C-reactive protein (mg/L) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  5. 1 week result on plasma creatinine

    Time frame: 7 days

    Change ("∆-value") between plasma creatinine (umol/L) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  6. 1 week result on plasma osmolality

    Time frame: 7 days

    Change ("∆-value") between plasma osmolality (mosm/kg H2O) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  7. 1 week result on urine osmolality

    Time frame: 7 days

    Change ("∆-value") between urine osmolality (mosm/kg H2O) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  8. 1 week result on blood pressure

    Time frame: 7 days

    Change ("∆-value") between blood pressure (mmHg) at end of control week and post-intervention values will be calculated.

    Significance of differences between each intervention and the time-control will be tested using paired t-test or Wilcoxon's paired rank test, depending on normality of distributions.

  9. Acute 4-hour effect of intervention on copeptin

    Time frame: 4 hours

    To test the hypothesis that acute coffee or water load affects plasma copeptin levels (pmol/L), we will perform paired t-tests (or Wilcoxon's paired rank test in case of no normal distribution) between individual 0 min values (immediately before acute load) and repeated post load values taken each 30 min during 4 hours.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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