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Completed

NCT Number: NCT01498523

The Glycaemic and Insulinaemic Responses of Camel Milk

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

About this study

There is no detailed description

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Camel milk

Other

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 names: Dromedary milk

camel milk powder solution

Other

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 names: Dromedary milk powder

raw cow milk

Other

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 names: Bovine milk

glucose solution

Other

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 names: Sugar solution

Primary outcomes

  1. blood glucose and insuline concentrations

    Time frame: 2 months

    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 outcomes

  1. Blood amino acids concentration

    Time frame: 2 months

    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.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

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

Acronym: GLUCAM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2011
Registry last updated
Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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