To investigate if the GH-promoting effect of gelatine- protein is present in non-overweight and overweight elderly people.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
sarcopenie en obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is the GH-concentration after ingestion of
placebo and protein. This is determined by blood-sampling.
Secondary outcome
The second study endpoint is the insulin-concentration after ingestion of
placebo and protein. This is determined by blood-sampling.
Another endpoint is the correlation between the effect of standard clinical
GHST and the protein-drink on GH-secretion.
Correlation between the amount of visceral fat mass (estimated with DXA) and
the GH concentrations after standard clinical GHST and protein-drink.
Background summary
Elderly and visceral obese persons are characterized by low GH-concentrations.
GH is importent for maintanence of muscle mass and decrease in fat-mass (body
composition) and is stimulated by intake of gelatin protein.
Study objective
To investigate if the GH-promoting effect of gelatine- protein is present in
non-overweight and overweight elderly people.
Study design
Randomized cross-over design with 3 conditions.
Intervention
-GHRH+ARG-test: Test contains GHRH: GHRH1-29; (GEREF, Serono, Italy) is
intravenous infused in an amount of 100µg/kg bodyweight after a 30 minute rest
period. Serum growth hormone concentrations were measured at 0, 15, 30, 60, 90
and 120 minutes. Arginine hydrochloride (Fresenius Kabi Clayton Nederland ), 30
gram intravenous infused over 30 min from 0 to 30 min, up to a maximum of 30 g.
ARG infusion starts at the same time then GHRH infusion.
-Placebo: The placebo-test contains only water and sugarfree syrup. For the
placebo test, subjects will arrive in the morning (08:00h) in fasted state,
they are instructed to drink and eat nothing after 22:00h the day before the
testday and limit their physical activity the day before the tests (no sport).
At 8:30h, subjects receive a drink, which contains 500 ml water and 8 lemon
drops. Blood samples are taken every 20 minutes for 300 minutes to measure
growth hormone levels.
-Protein-drink: In this test subjects receive a protein drink, containing
complete soy protein, solved in water with 8 lemon drops. Soy protein is a
dietary protein, containing relatively high levels of arginine and has been
shown in our preceding studies to be a more potent GH stimulator in adult women
compared with an amino acid solution containing arginine[6].
For the protein test, subjects will arrive in the morning (08:00h) in fasted
state, they are instructed to drink and eat nothing after 22:00h the day before
the testday and limit their physical activity the day before the tests (no
sport). At 8:30 h, subjects receive a drink, which contains 0.6gram per kg
bodyweight. Blood samples are taken every 20 minutes for 300 minutes to measure
growth hormone levels.
-DXA-scan to estimate the amount of visceral fat mass
Study burden and risks
This research is neither beneficial nor harmful to the subjects. Allergy
reactions on soy protein are possible, but in the screening, test persons with
a known allergy for soy are excluded. The possible side-effect of the GHRH are
hot-flushes and thereby an increased blood pressure and hart-rate for a short
time. Possible side-effects of ARG are nausea and vomiting. There are no
further risks for the subjects in undergoing the standard clinical
GHRH+ARG-test or in consuming the test-drink, as the GHRH+ARG-test is a
standard clinical test, using in hospitals to determine GHDeficiency and the
protein used are food-proof and present in our daily diet.
The blood sampling in this study does not include any other risks for the
subjects, apart from its usual risk of minor bruising.
Universiteitssingel 50,
6200MD
Nederland
Universiteitssingel 50,
6200MD
Nederland
Listed location countries
Age
Inclusion criteria
women, post-menopausal, age between 55-65, 8 visceral obese (BMI 27-33 and Waist/hip-ratio>0.85), 8 normal weight (BMI20-25, wasit/hip<0.85)
Exclusion criteria
Use of medication, instabel weight, disorders as cardiovascular diseases, diabetics, cancer, gelatin-allergic
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 | NL21516.068.08 |