Water and Coffee Intervention in Humans

NCT06165185 | Completed

• 1 other identifier: 2010_740
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Excess Intake of Macronutrients; Excess Intake of Micronutrients; Vasopressin Low

Keywords

copeptin, water, coffee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 1 week result on plasma glucose

  7 days

• 1 week result on plasma insulin

  7 days

• 1 week result on plasma glucagon

  7 days

• 1 week result on plasma C-reactive protein

  7 days

• 1 week result on plasma creatinine

  7 days

Study Arms (3)

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.

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.

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.

Other: Control

Interventions

Water OTHER

Please see the associated arm description

Water

Coffee OTHER

Please see the associated arm description

Coffee

Control OTHER

Please see the associated arm description

Control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects Age 20-70 years

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

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

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Water; Coffee

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2011
• Primary Completion: January 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 11, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)