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Effect of Camel Milk on Insulin and Incretin Response

Primary Purpose

Insulin Sensitivity, Glucose Tolerance

Status

Unknown status

Phase

Not Applicable

Locations

United Arab Emirates

Study Type

Interventional

Intervention

Camel milk

Cow milk

About this trial

This is an interventional other trial for Insulin Sensitivity

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Imperial College London Diabetes CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy individuals (camel milk)

Healthy individuals (cow milk)

Arm Description

Outcomes

Primary Outcome Measures

Glucose response to camel and cow milk

The difference between interventions in terms of peak of glucose

Response of glucose to camel and cow milk

The difference between interventions in terms of area under the curve

Secondary Outcome Measures

Insulin response to camel and cow milk

The difference between interventions in terms of peak

Response of insulin to camel and cow milk

The difference between interventions in terms of area under the curve

GLP-1 response to camel and cow milk

The difference between interventions in terms of peak

Response of GLP-1 to camel and cow milk

The difference between interventions in terms of area under the curve

C-peptide response to camel and cow milk

The difference between interventions in terms of peak

Response of C-peptide to camel and cow milk

The difference between interventions in terms of area under the curve

Full Information

NCT ID

NCT03725969

First Posted

October 14, 2018

Last Updated

February 11, 2020

Sponsor

Imperial College London Diabetes Centre

1. Study Identification

Unique Protocol Identification Number

NCT03725969

Brief Title

Effect of Camel Milk on Insulin and Incretin Response

Official Title

The Effect of Camel Milk on Insulin and Incretin Response to a Mixed-meal Challenge in People With Normal Glucose Tolerance

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London Diabetes Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Sensitivity, Glucose Tolerance

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Masking Description

Double-blind

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy individuals (camel milk)

Arm Type

Experimental

Arm Title

Healthy individuals (cow milk)

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Camel milk

Intervention Description

Camel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Cow milk

Intervention Description

Cow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions

Primary Outcome Measure Information:

Title

Glucose response to camel and cow milk

Description

The difference between interventions in terms of peak of glucose

Time Frame

5 months

Title

Response of glucose to camel and cow milk

Description

The difference between interventions in terms of area under the curve

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Insulin response to camel and cow milk

Description

The difference between interventions in terms of peak

Time Frame

5 months

Title

Response of insulin to camel and cow milk

Description

The difference between interventions in terms of area under the curve

Time Frame

5 months

Title

GLP-1 response to camel and cow milk

Description

The difference between interventions in terms of peak

Time Frame

5 months

Title

Response of GLP-1 to camel and cow milk

Description

The difference between interventions in terms of area under the curve

Time Frame

5 months

Title

C-peptide response to camel and cow milk

Description

The difference between interventions in terms of peak

Time Frame

5 months

Title

Response of C-peptide to camel and cow milk

Description

The difference between interventions in terms of area under the curve

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Nader Lessan, MBBS MD FRCP

Organizational Affiliation

Imperial College London Diabetes Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imperial College London Diabetes Centre

City

Abu Dhabi

ZIP/Postal Code

48338

Country

United Arab Emirates

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nader Lessan, MBBS MD FRCP

Phone

+971 2 404 0800

nlessan@icldc.ae

First Name & Middle Initial & Last Name & Degree

Hinda Daggag, PhD

Phone

+971 2 404 0800

hdaggag@icldc.ae

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Camel Milk on Insulin and Incretin Response

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