The Glycaemic and Insulinaemic Responses of Camel Milk (GLUCAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01498523
First received: December 20, 2011
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Healthy
Other: Camel milk
Other: camel milk powder solution
Other: raw cow milk
Other: Glucose solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: An Explorative Study to Characterize the Glycaemic and Insulinaemic Responses of Regular Camel Milk and Camel Milk Powder

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • blood glucose and insuline concentrations [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood amino acids concentration [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: raw camel milk 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.
Other Name: Dromedary milk
Experimental: camel milk powder solution Other: 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.
Other Name: Dromedary milk powder
Active Comparator: raw cow milk Other: 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.
Other Name: Bovine milk
Active Comparator: Glucose solution Other: 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.
Other Name: Sugar solution

Detailed Description:

There is no detailed description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498523

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6703 HA
Sponsors and Collaborators
Wageningen University
Investigators
Study Director: Edith Feskens, Prof.Dr.Ir. Wageningen University
Principal Investigator: Anne Wanders, MSc Wageningen University
Principal Investigator: Monique van Nielen Wageningen University
  More Information

Additional Information:
No publications provided

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01498523     History of Changes
Other Study ID Numbers: 38520
Study First Received: December 20, 2011
Last Updated: February 3, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
Camel milk
Postprandial glycaemic response
postprandial insulinaemic response
Glycaemic index

ClinicalTrials.gov processed this record on July 23, 2014