To assess the diuretic effect of three standard glasses of beer, red wine and spirits in euhydrated elderly men
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The objective of this investigation is to assess the diuretic effect of three
standard glasses of beer, red wine and spirits in euhydrated elderly men.
Secondary outcome
To assess the effect of three standard glasses of beer, red wine and spirits on
urinary osmolality, potassium and sodium levels in euhydrated elderly men.
Background summary
Alcohol consumption is known to increase urine output, which could interfere
with normal hydration. The underlying mechanism of this effect is possibly due
to the inhibition of the release of antidiuretic hormone, vasopressin. So far,
no consistent theory exists on the extent of diuresis by alcohol consumption.
For health communication purposes, specifically towards elderly who have an
increased risk of dehydration, it is important to know the exact extent of the
diuretic effect of different alcoholic beverages. To the best of our knowledge,
no studies have examined the diuretic effect of commercial available weak and
strong alcoholic beverages in normal life settings.
Study objective
To assess the diuretic effect of three standard glasses of beer, red wine and
spirits in euhydrated elderly men
Study design
The study has a diet-controlled randomized cross-over design (within subject
design) in which participants consume 3 standard glasses of beer,
non-alcoholic beer, red wine, non-alcoholic red wine, spirits or water at 6
different test sessions. The order in which participants are exposed to the
test beverages is randomized and counterbalanced.
Intervention
Subjects will participate in six experimental trials, each separated by a
period of at least seven days. Beverage types vary between the six trials.
Subjects are randomly exposed to: beer (lager), non-alcoholic beer, red wine,
non-alcoholic red wine, spirits (jenever) or water.
During the test sessions, they will collect urine starting after the first
morning urine and the total diet will be provided (same standard diet and lunch
on each test day). The diet will have different levels of energy intake per
day, depending on the body weight of the subjects. During each trial day
subjects are not allowed to eat or drink anything but the foods supplied and
they should maintain their habitual physical activity pattern. Subjects will
consume all foods and drinks at home except for a warm meal in the afternoon
that is provided at the research facility. Subjects will consume 3 standard
glasses of one of the 6 test beverages within 30 minutes after the meal has
started. They will stay for 4 hours after the meal during which they will have
to give multiple urine samples (after 1, 2, 3, 4 hours). Also, they have to
collect urine from the moment they leave the research facilities until the next
morning at home. Before each breakfast, lunch and dinner subjects will have to
take one PABA tablet (3 times per day).
Study burden and risks
There is no direct (health-related) benefit for the participant. Three of the 6
test beverages contain alcohol and when consumed these subjects not allowed to
leave the research area until their breath alcohol concentration is within the
accepted range. Except for the blood sampling for screening (plasma
concentrations of creatinine and urea) all functional measurements during the
trial (urine volume, urine osmolality, urine sodium, potassium and PABA, body
weight and breath alcohol concentrations) are non-invasive and risks are
therefore minimal.
During the test sessions, the total diet will be provided (same standard diet
and lunch on each test day).
The time investment requested from the participants excluding travel time is in
total approximately 30 hours for 18 visits and screening
Bomenweg 4
Wageningen 6703 HD
NL
Bomenweg 4
Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
See page 11 of the protocol:
• Age between 60-75 yrs
• Male gender
• BMI between 20-30 kg/m2
• Normal renal function (normal plasma concentrations of creatinine and urea)
• Used to drink alcoholic beverages
• Healthy (as judged by the participant)
Exclusion criteria
See page 11 of the protocol:
• Usage of an energy restricted diet during the last two months
• Weight loss or weight gain of 5 kg or more during the last two months
• Having endocrine, bowel or neurological disorders that could interfere with outcome variables
• Usage of systemic medication that could interfere with outcome variables (e.g. diuretics)
• Being allergic/intolerant for products under study
• Smoking more than seven cigarettes/cigars per week
• Drinking on average more than 21 alcoholic beverages a week
• Being an alcoholic or history of alcoholism
• Family history of alcoholism (loss of control, tolerance or withdrawal symptoms towards alcohol in direct family)
• Current participation in other scientific research
• Being employee, thesis student or intern of the Division of Human Nutrition (WUR)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL49923.081.14 |