Our primary objective is to assess the postprandial anabolic response to mixed meal testing in both young and elderly, healthy volunteers. Our secondary objectives are to assess the effect of MMT on glucoregulatory and gut hormones, lipid profiles,…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are postprandial bile metabolism expressed as
concentration, area under the curve and inflammatory response as determined by
the whole blood leukocyte counts and plasma cytokines.
Secondary outcome
. To assess the effect of a MMT on:
* Glucoregulatory and gut hormones
* Lipid profiles
* Resting energy expenditure
* Appetite and satiety
* Body composition
* Micriobiome
Background summary
Rationale: Malnutrition, anorexia and sarcopenia are highly prevalent clinical
conditions in the elderly and have a major impact on morbidity and mortality
among this subpopulation. The mechanism behind these conditions remains
unclear. Research has shown that there is a decreased GLP-1 response in
elderly, in comparison with younger subjects. The role of bile acids herein is
remains unclear but could be of importance.
In this study, we aim to investigate the difference of postprandial bile acid
response to mixed meal testing in young and elderly, healthy volunteers. This
study is of importance because it may give us a better understanding of the
anabolic and inflammatory response to mixed meal testing in elderly compared to
young healthy volunteers.
The above has been described more extensively in the introduction of our
protocol (page numbers: 10+11)
Study objective
Our primary objective is to assess the postprandial anabolic response to mixed
meal testing in both young and elderly, healthy volunteers. Our secondary
objectives are to assess the effect of MMT on glucoregulatory and gut hormones,
lipid profiles, resting energy expenditure, appetite and satiety, body
composition and microbiome.
Study design
This study is designed as a single-center, observational study. We will include
9 healthy lean male subjects and 9 healthy elderly subjects. Each subject will
undergo 1 mixed meal test.
Study burden and risks
Burden
There will be 2 study visits (1 screening, 1 MMT) in the AMC. The screening
visit will take 30 minutes, including physical examination and an overnight
fasted venous blood withdrawal (12 ml). The MMT will take approximately 7
hours. During the MMT, subjects will receive a standardized liquid meal
consisting of 25% of daily energy expenditure in the form of Nutridrink
(Nutricia, Zoetermeer), followed by frequent blood sampling from an intravenous
(IV) cannula (total blood withdrawal 120 ml). The total amount of blood
withdrawal during the study will be 132 ml. Indirect calorimetry requires that
the subjects breathe into a mask for 20 minutes while lying in supine position.
Subjects will receive ¤ 65,- for mixed meal test as reimbursement for allocated
time and travelling expenses, after completion of the study.
Risks
There is a risk of hematoma and flebitis with the insertion of a intravenous
cannula.
Benefit
There is no benefit for the volunteers. This research will provide insight into
the anabolic and inflammatory response to mixed meal testing in elderly, which
may help us to develop strategies to combat sarcopenia and anorexia in elderly.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Ability to provide informed consent
- 18-30 years or older than 65 years at the time of signing the informed consent
- Body mass index (BMI) 18.5- 25 kg/m2
- Caucasian men
- General good health as determined by medical history, physical examination
and blood chemistry by a physician.
- HOMA-IR index: * 2.0 (measured as fasting insulin (pmol/L) x fasting glucose
(mmol/L) / 135)
Exclusion criteria
- Major illness in the past 3 months
- Use of any medication
- Gastro-intestinal disease that may influence bile acid signalling metabolism
- History of cholecystectomy or other bile duct abnormalities
- Tobacco smoking
- Drugs abuse
- Alcoholism (>3 units a day)
- Blood chemistry (fasted):
* Creatinine >120 µM
* Glucose * 5.6 mmol/L
* >2 times upper limit reference interval of the following: ASAT, ALAT, GGT, AP
- Strenuous exercise for at least 3 days prior to each study day, defined as
more than 1 hour of exercise per day.
- Hypersensitivity to substances in Nutridrink
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 | NL66932.018.18 |