The Glycaemic and Insulinaemic Responses of Camel Milk

NCT01498523 | Completed

• 1 other identifier: 38520
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Camel milk; Postprandial glycaemic response; postprandial insulinaemic response; Glycaemic index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood amino acids concentration

  2 months

Study Arms (4)

raw camel milk

EXPERIMENTAL

Other: Camel milk

camel milk powder solution

EXPERIMENTAL

Other: camel milk powder solution

raw cow milk

ACTIVE COMPARATOR

Other: raw cow milk

Glucose solution

ACTIVE COMPARATOR

Other: Glucose solution

Interventions

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.

Also known as: Dromedary milk

raw camel 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.

Also known as: Dromedary milk powder

camel milk powder solution

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.

Also known as: Bovine milk

raw cow 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.

Also known as: Sugar solution

Glucose solution

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating females;
• Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome;
• \> 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.

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

Location

Study Officials

• Edith Feskens, Prof.Dr.Ir.

  Wageningen University

  STUDY DIRECTOR

• Anne Wanders, MSc

  Wageningen University

  PRINCIPAL INVESTIGATOR

• Monique van Nielen

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 23, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

NL (1)