The Glycaemic and Insulinaemic Responses of Camel Milk

Healthy Clinical Trial

— GLUCAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498523
• Other study ID #: 38520
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: February 3, 2012
• Start date: December 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

There is no detailed description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Camel milk
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.
• camel milk powder solution
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.
• raw cow milk
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.
• Glucose solution
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.

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Division of Human Nutrition, Wageningen University