Insulin SensitivityNCT03725969
Effect of Camel Milk on Insulin and Incretin Response
A study testing Camel milk and Cow milk in people with Insulin Sensitivity and Glucose Tolerance, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial summary
To examine the differential effect of camel and cow milk on the physiological response, to a liquid mixed-meal challenge, in people with normal glucose tolerance Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Glucose Tolerance
- What is being tested?
- Camel milk and Cow milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Feb 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal glucose tolerance
- BMI < 30 kg/m2
Who cannot join
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
- Impaired fasting glucose or impaired glucose tolerance
- Lactose intolerance
- Weight loss / gain ≥ 5 kg in the preceding two months
- Use of estrogenic drugs or corticosteroids
Show all 13Show fewer
- Known hypertriglyceridemia requiring treatment
- History of heart attack, angina or cardiovascular disorder
- History of malignant tumor
- Pregnant or lactating women
- Hemoglobin < 12 for any reason
- Recent surgery or major hemorrhage
- History of bariatric or metabolic surgery
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Imperial College London Diabetes Centre
Abu Dhabi, 48338
Nader Lessan, MBBS MD FRCP, +971 2 404 0800, nlessan@icldc.ae
Hinda Daggag, PhD, +971 2 404 0800, hdaggag@icldc.ae
About this study
Official title: The Effect of Camel Milk on Insulin and Incretin Response to a Mixed-meal Challenge in People With Normal Glucose Tolerance
To examine the differential effect of camel and cow milk on the physiological response, to a liquid mixed-meal challenge, in people with normal glucose tolerance
Read the detailed description
Camel milk is used as a traditional remedy throughout the Middle East and Indian Subcontinent for conditions such as type 2 diabetes and dyslipidemia. It is currently unclear how such an effect could be mediated in vivo and studies are limited. We performed this study as a pilot experiment to assess the effects of camel milk on Insulin, Glucose, GLP-1, C-peptide and Lipid profile.
- Conditions
- Insulin Sensitivity, Glucose Tolerance
- Being tested
- Camel milk, Cow milk
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camel milkDietary supplement
Camel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions
Cow milkDietary supplement
Cow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals (camel milk) | Experimental | Not described Receives: Dietary Supplement: Camel milk |
| Healthy individuals (cow milk) | Experimental | Not described Receives: Dietary Supplement: Cow milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response to camel and cow milk
The difference between interventions in terms of peak of glucose
Measured: 5 months
Response of glucose to camel and cow milk
The difference between interventions in terms of area under the curve
Measured: 5 months
Secondary outcomes (6)
Insulin response to camel and cow milk
The difference between interventions in terms of peak
Measured: 5 months
Response of insulin to camel and cow milk
The difference between interventions in terms of area under the curve
Measured: 5 months
GLP-1 response to camel and cow milk
The difference between interventions in terms of peak
Measured: 5 months
Response of GLP-1 to camel and cow milk
The difference between interventions in terms of area under the curve
Measured: 5 months
C-peptide response to camel and cow milk
The difference between interventions in terms of peak
Measured: 5 months
Response of C-peptide to camel and cow milk
The difference between interventions in terms of area under the curve
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Feb 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Nader Lessan, MBBS MD FRCP, Principal investigator, Imperial College London Diabetes Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725969
- Sponsor's protocol ID
- IREC033
- Status last verified
- Feb 2020
- First submitted
- 14 Oct 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Camel Milk on Insulin and Incretin Response to a Mixed-meal Challenge in People With Normal Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03725969
- Acronym / sponsor ID
- IREC033
- Conditions
- Insulin Sensitivity, Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the differential effect of camel and cow milk on the physiological response, to a liquid mixed-meal challenge, in people with normal glucose tolerance
Detailed description
Camel milk is used as a traditional remedy throughout the Middle East and Indian Subcontinent for conditions such as type 2 diabetes and dyslipidemia. It is currently unclear how such an effect could be mediated in vivo and studies are limited. We performed this study as a pilot experiment to assess the effects of camel milk on Insulin, Glucose, GLP-1, C-peptide and Lipid profile.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals (camel milk) | Experimental | Dietary Supplement: Camel milk |
| Healthy individuals (cow milk) | Experimental | Dietary Supplement: Cow milk |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal glucose tolerance
- BMI < 30 kg/m2
Key exclusion criteria (13 listed)
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
- Impaired fasting glucose or impaired glucose tolerance
- Lactose intolerance
- Weight loss / gain ≥ 5 kg in the preceding two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camel milkCamel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions | Dietary supplement | Healthy individuals (camel milk) |
| Cow milkCow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions | Dietary supplement | Healthy individuals (cow milk) |
Primary outcome
Glucose response to camel and cow milk
Time frame: 5 months
The difference between interventions in terms of peak of glucose
Response of glucose to camel and cow milk
Time frame: 5 months
The difference between interventions in terms of area under the curve
6 secondary outcomes
Insulin response to camel and cow milk
Time frame: 5 months
Response of insulin to camel and cow milk
Time frame: 5 months
GLP-1 response to camel and cow milk
Time frame: 5 months
Response of GLP-1 to camel and cow milk
Time frame: 5 months
C-peptide response to camel and cow milk
Time frame: 5 months
Response of C-peptide to camel and cow milk
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Insulin Sensitivity
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Insulin Resistance, Obesity
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Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imperial College London Diabetes Centre
Abu Dhabi, United Arab Emirates
Dr Nader Lessan, MBBS MD FRCP principal investigator
Imperial College London Diabetes Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camel milk and Cow milk in people with Insulin Sensitivity and Glucose Tolerance, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose response to camel and cow milk (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.