To characterize the glycaemic and insulinaemic responses of regular camel milk and camel milk powder in healthy adults.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameters are postprandial blood glucose and insulin responses.
Secondary outcome
Amino acid response in blood
Background summary
Recently, human, animal and epidemiological studies suggested that camel milk
has a hypoglycaemic activity. However, a mechanism and reasons for this
activity have not been sufficiently studied. Therefore, a study on a glycaemic
and insulinaemic responses of regular camel milk and camel milk powder is
needed.
Study objective
To characterize the glycaemic and insulinaemic responses of regular camel milk
and camel milk powder in healthy adults.
Study design
Two hour post prandial glucose and insulin responses of 4 treatments: regular
camel milk, camel milk powder, regular cow milk and glucose will be tested in a
randomised double blind cross over design. The test will be conducted on 4
separate days with at least 2 days wash out.
Intervention
4 treatments will be randomized over 4 measurement days. On each day, subjects
will receive 600ml of test product containing 25g available carbohydrate which
they need to ingest within 10 minutes. Finger-prick capillary blood samples
will be taken at fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion
of the test product for blood glucose analysis. Venapunctures will be taken at
fasting, 30 and 75 minutes after ingestion of the test product for insulin and
amino acid analysis.
Study burden and risks
This intervention is non-therapeutic to the subjects. The risk associated with
participation is negligible and the burden can be considered low. Before
subjects are able to participate in this study they will have to fill out a
brief questionnaire, and have their fasting blood glucose measured, in order to
ensure they fit the inclusion criteria of the study. Once entering the study,
each subject will have to visit the research centre 4 times for the
postprandial tests. On each measurement day, each subject will be required to
have fasted for at least ten hours before (an overnight fast). Each subject
will have 7 finger-prick blood samples and 3 venapunctures taken during each
visit. A maximum amount of 50 ml blood is drawn per day.
Bomenweg 2
6703 HD Wageningen
NL
Bomenweg 2
6703 HD Wageningen
NL
Listed location countries
Age
Inclusion criteria
age: 18-35
healthy as judged by the participant
BMI: 18.5-25 kg/m2
Exclusion criteria
• Fasting blood glucose levels >100 mg/dl or 5.6 mmol/l;
• Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome;
• Lactose intolerance or experiencing discomfort after (camel)milk consumption;
• Weight loss or gain of more than 5 kg in the last two months;
• Using an energy restricted diet during the last 2 months;
• Smokers;
• Use of medications other than birth control, paracetamol, aspirin, asthma or hay fever;
• For women: Pregnant or lactating ;
• Previous problems with blood sampling.
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 | NL38520.081.11 |