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

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

Study Overview

• Status: Unknown
• Conditions: Glucose Tolerance; Insulin Sensitivity
• Intervention / Treatment: Dietary supplement: Camel milk; Dietary supplement: Cow milk

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 48338
    • Recruiting
    • Imperial College London Diabetes Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Normal glucose tolerance
• BMI < 30 kg/m2

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy individuals (camel milk)	Dietary supplement: Camel milk; Camel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions
Experimental: Healthy individuals (cow milk)	Dietary supplement: Cow milk; Cow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin response to camel and cow milk	The difference between interventions in terms of peak	5 months
Response of insulin to camel and cow milk	The difference between interventions in terms of area under the curve	5 months
GLP-1 response to camel and cow milk	The difference between interventions in terms of peak	5 months
Response of GLP-1 to camel and cow milk	The difference between interventions in terms of area under the curve	5 months
C-peptide response to camel and cow milk	The difference between interventions in terms of peak	5 months
Response of C-peptide to camel and cow milk	The difference between interventions in terms of area under the curve	5 months

Collaborators and Investigators

• Sponsor: Imperial College London Diabetes Centre
• Investigators: Principal Investigator: Dr Nader Lessan, MBBS MD FRCP, Imperial College London Diabetes Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 28, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: IREC033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No