Water and Coffee Intervention in Humans

Excess Intake of Macronutrients Clinical Trial

Official title:

Water and Coffee Intervention in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165185
• Other study ID #: 2010_740
• Status: Completed
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 31, 2016
• Est. primary completion date: January 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

Healthy subjects Age 20-70 years

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Excess Intake of Macronutrients

Intervention

Other:
• Water
Please see the associated arm description
• Coffee
Please see the associated arm description
• Control
Please see the associated arm description

Locations

Country	Name	City	State
Sweden	Clinical research unit, Internal medicine department, Skåne University Hospital in Malmö	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 week result on plasma copeptin	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.	7 days
Secondary	1 week result on plasma glucose	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.	7 days
Secondary	1 week result on plasma insulin	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.	7 days
Secondary	1 week result on plasma glucagon	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.	7 days
Secondary	1 week result on plasma C-reactive protein	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.	7 days
Secondary	1 week result on plasma creatinine	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.	7 days
Secondary	1 week result on plasma osmolality	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 days
Secondary	1 week result on urine osmolality	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.	7 days
Secondary	1 week result on blood pressure	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.	7 days
Secondary	Acute 4-hour effect of intervention on copeptin	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.	4 hours