Clinical trial NCT01498523: The Glycaemic and Insulinaemic Responses of Camel Milk
Official title: An Explorative Study to Characterize the Glycaemic and Insulinaemic Responses of Regular Camel Milk and Camel Milk Powder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Camel milk
Postprandial glycaemic response
postprandial insulinaemic response
Glycaemic index
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: There is no detailed description

Eligibility criteria: Inclusion Criteria:

* Healthy: as judged by the subjects;
* Age: 18 to 35.

Exclusion Criteria:

* Pregnant or lactating females;
* Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome;
* 18.5 \> BMI \> 25 kg/m2;
* Lactose intolerance or experiencing discomfort after 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;
* Fasting blood glucose levels \>100 mg/dl or 5.6 mmol/l (18);
* Smokers;
* Use of medications other than birth control, paracetamol, aspirin, asthma or hay fever;
* Previous problems with blood sampling.

Primary outcomes:
measure: blood glucose and insuline concentrations
timeFrame: 2 months
Secondary outcomes:
measure: Blood amino acids concentration
timeFrame: 2 months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Edith Feskens, Prof.Dr.Ir.
role: STUDY_DIRECTOR
affiliation: Wageningen University
name: Anne Wanders, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Monique van Nielen
role: PRINCIPAL_INVESTIGATOR
References: