Effect of Camel Milk on Insulin and Incretin Response
The Effect of Camel Milk on Insulin and Incretin Response to a Mixed-meal Challenge in People With Normal Glucose Tolerance
1 other identifier
interventional
15
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 14, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFebruary 12, 2020
February 1, 2020
3.9 years
October 14, 2018
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Glucose response to camel and cow milk
The difference between interventions in terms of peak of glucose
5 months
Response of glucose to camel and cow milk
The difference between interventions in terms of area under the curve
5 months
Secondary Outcomes (6)
Insulin response to camel and cow milk
5 months
Response of insulin to camel and cow milk
5 months
GLP-1 response to camel and cow milk
5 months
Response of GLP-1 to camel and cow milk
5 months
C-peptide response to camel and cow milk
5 months
- +1 more secondary outcomes
Study Arms (2)
Healthy individuals (camel milk)
EXPERIMENTALHealthy individuals (cow milk)
EXPERIMENTALInterventions
Camel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions
Cow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions
Eligibility Criteria
You may qualify if:
- Normal glucose tolerance
- BMI \< 30 kg/m2
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London Diabetes Centre
Abu Dhabi, 48338, United Arab Emirates
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Nader Lessan, MBBS MD FRCP
Imperial College London Diabetes Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2018
First Posted
October 31, 2018
Study Start
February 1, 2017
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share