The Glycaemic and Insulinaemic Responses of Camel Milk

Study Overview
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Brief Summary
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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
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There is no detailed description

Official Title
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An Explorative Study to Characterize the Glycaemic and Insulinaemic Responses of Regular Camel Milk and Camel Milk Powder

Conditions
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Healthy

Intervention / Treatment
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* Other: Camel milk
* Other: camel milk powder solution
* Other: raw cow milk
* Other: Glucose solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: raw camel milk<br> | Other: Camel milk<br>* 600ml of raw camel milk will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.<br>* Other names: Dromedary milk;|
| Experimental: camel milk powder solution<br> | Other: camel milk powder solution<br>* 72g camel milk powder will be dissolved in 540ml water to make 600ml camel milk powder solution. This will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.<br>* Other names: Dromedary milk powder;|
| Active Comparator: raw cow milk<br> | Other: raw cow milk<br>* 50ml water will be added to 550ml raw cow milk to make 600ml cow milk. This will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.<br>* Other names: Bovine milk;|
| Active Comparator: Glucose solution<br> | Other: Glucose solution<br>* 25g glucose will be dissolved in 600ml water, and this will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.<br>* Other names: Sugar solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose and insuline concentrations | During the test session, subjects will drink raw camel milk, camel milk powder solution, raw cow milk and glucose solution. At time points 0, 15, 30, 45, 60, 90 and 120 minutes blood glucose level will be measured by finger-prick blood samples. Also, at time points 0, 30, 75 minutes insulin level will be measured by venepuncture blood samples. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood amino acids concentration | During the test session, subjects will drink raw camel milk, camel milk powder solution, raw cow milk and glucose solution. At time points 0, 30, 75 minutes blood amino acids level will be measured by venepuncture blood samples. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Camel milk, Postprandial glycaemic response, postprandial insulinaemic response, Glycaemic index