Clinical trial NCT06165185: Water and Coffee Intervention in Humans
Official title: Water and Coffee Intervention in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excess Intake of Macronutrients
Excess Intake of Micronutrients
Vasopressin Low
Keywords: copeptin, water, coffee
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will be 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. 3 weeks of wash-out between each intervention week.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Healthy subjects Age 20-70 years

Exclusion Criteria:

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

Primary outcomes:
measure: 1 week result on plasma copeptin
timeFrame: 7 days
Secondary outcomes:
measure: 1 week result on plasma glucose
timeFrame: 7 days
measure: 1 week result on plasma insulin
timeFrame: 7 days
measure: 1 week result on plasma glucagon
timeFrame: 7 days
measure: 1 week result on plasma C-reactive protein
timeFrame: 7 days
measure: 1 week result on plasma creatinine
timeFrame: 7 days
measure: 1 week result on plasma osmolality
timeFrame: 7 days
measure: 1 week result on urine osmolality
timeFrame: 7 days
measure: 1 week result on blood pressure
timeFrame: 7 days
measure: Acute 4-hour effect of intervention on copeptin
timeFrame: 4 hours
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Clinical research unit, Internal medicine department, Skåne University Hospital in Malmö
Study officials:
References: