Excess Intake of MacronutrientsNCT06165185
Water and Coffee Intervention in Humans
A study testing Water and Coffee in people with Excess Intake of Macronutrients and Excess Intake of Micronutrients, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Excess Intake of Macronutrients, Excess Intake of Micronutrients, Vasopressin Low
- What is being tested?
- Water and Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2011to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects Age 20-70 years
Who cannot join
- medication (except oral contraceptives) any type of acute illness any type of chronic illness
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical research unit, Internal medicine department, Skåne University Hospital in Malmö
Malmö, 20502
About this study
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.
Read the 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.
- Being tested
- Water, Coffee, Control
- Keywords
- copeptin, water, coffee
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Please see the associated arm description
CoffeeOther
Please see the associated arm description
ControlOther
Please see the associated arm description
| Study group | Role | What they receive |
|---|---|---|
| Water | Experimental | At intervention day 1, during a maximum time period of 20 minutes, subjects will ingest 1 L of water (still bottled water) to map the acute water effect on the vasopressin marker copeptin (repeated blood sampling every 30 minutes for 4 hours). Day 1 then continues with the rest of the daily intake, i.e., 2 L of extra water (i.e. in addition to each subject's habitual food and fluid intake).
Intervention day 2-7: 3 L extra water per day in addition to each subject's habitual food and fluid intake. Receives: Other: Water |
| Coffee | Experimental | At intervention day 1, during a maximum time period of 20 minutes, subjects will ingest 4 dL of coffee to map the acute coffee effect on the vasopressin marker copeptin (repeated blood sampling every 30 minutes for 4 hours). Day 1 then continues with the rest of the daily intake, i.e., 6dL of extra coffee (i.e. in addition to each subject's habitual food and fluid intake).
Intervention day 2-7: 1 L extra coffee per day in addition to each subject's habitual food and fluid intake. Receives: Other: Coffee |
| Control | Experimental | At intervention day 1, during a maximum time period of 20 minutes, subjects will ingest just 10 ml of water to map the acute effect on the vasopressin marker copeptin (repeated blood sampling every 30 minutes for 4 hours). Day 1 then continues with each subject's habitual food and fluid intake.
Intervention day 2-7: Each subject's habitual food and fluid intake. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (9)
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2011
- Primary completion31 Jan 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excess Intake of MacronutrientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165185
- Sponsor's protocol ID
- 2010_740
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water and Coffee Intervention in Humans
- ClinicalTrials.gov ID
- NCT06165185
- Acronym / sponsor ID
- 2010_740
- Keywords
- copeptin, water, coffee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Water | Experimental | Other: WaterAt intervention day 1, during a maximum time period of 20 minutes, subjects will ingest 1 L of water (still bottled water) to map the acute water effect on the vasopressin marker copeptin (repeated blood sampling every 30 minutes for 4 hours). Day 1 then continues with the rest of the daily intake, i.e., 2 L of extra water (i.e. in addition to each subject's habitual food and fluid intake). Intervention day 2-7: 3 L extra water per day in addition to each subject's habitual food and fluid intake. |
| Coffee | Experimental | Other: CoffeeAt intervention day 1, during a maximum time period of 20 minutes, subjects will ingest 4 dL of coffee to map the acute coffee effect on the vasopressin marker copeptin (repeated blood sampling every 30 minutes for 4 hours). Day 1 then continues with the rest of the daily intake, i.e., 6dL of extra coffee (i.e. in addition to each subject's habitual food and fluid intake). Intervention day 2-7: 1 L extra coffee per day in addition to each subject's habitual food and fluid intake. |
| Control | Experimental | Other: ControlAt intervention day 1, during a maximum time period of 20 minutes, subjects will ingest just 10 ml of water to map the acute effect on the vasopressin marker copeptin (repeated blood sampling every 30 minutes for 4 hours). Day 1 then continues with each subject's habitual food and fluid intake. Intervention day 2-7: Each subject's habitual food and fluid intake. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects Age 20-70 years
Key exclusion criteria (1 listed)
- medication (except oral contraceptives) any type of acute illness any type of chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterPlease see the associated arm description | Other | Water |
| CoffeePlease see the associated arm description | Other | Coffee |
| ControlPlease see the associated arm description | Other | Control |
Primary outcome
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.
9 secondary outcomes
1 week result on plasma glucose
Time frame: 7 days
1 week result on plasma insulin
Time frame: 7 days
1 week result on plasma glucagon
Time frame: 7 days
1 week result on plasma C-reactive protein
Time frame: 7 days
1 week result on plasma creatinine
Time frame: 7 days
1 week result on plasma osmolality
Time frame: 7 days
1 week result on urine osmolality
Time frame: 7 days
1 week result on blood pressure
Time frame: 7 days
Acute 4-hour effect of intervention on copeptin
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and Coffee in people with Excess Intake of Macronutrients and Excess Intake of Micronutrients, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 week result on plasma copeptin (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023; AzTrials last refreshed its copy on 1 Nov 2026.