Healthy Clinical Trial
Official title:
An Explorative Study to Characterize the Glycaemic and Insulinaemic Responses of Regular Camel Milk and Camel Milk Powder
Rationale: 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.
Objective: To explore the glycaemic and insulinaemic responses of regular camel milk and
camel milk powder in healthy adults.
Study design: In a randomised, single-blind and cross over 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 measured . Those treatments will be consumed in a
portion that contained 25g available carbohydrate. Finger-prick capillary blood samples will
be taken at fasting, and 15, 30, 45, 60, 90, 120 minutes after ingestion of the test
product. Venepunctures will be taken at fasting, 30 and 75 minutes after ingestion of the
test product. The measurements will be conducted on 4 separate days with at least 2 days
wash out.
Study population: 20 healthy volunteers aged 18 to 35 years, with BMI between 18.5 to 25
kg/m2.
Intervention: The treatments are regular camel milk, camel milk powder, regular cow milk and
glucose. These are standardized to 600ml containing 25g available carbohydrate.
Main study parameters/endpoints: Main parameters are postprandial blood glucose and insulin
responses. Secondary parameters: amino acid composition and glycemic index.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: 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.
There is no detailed description ;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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