NCT03725969

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

3.9 years

First QC Date

October 14, 2018

Last Update Submit

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)

EXPERIMENTAL
Dietary Supplement: Camel milk

Healthy individuals (cow milk)

EXPERIMENTAL
Dietary Supplement: Cow milk

Interventions

Camel milkDIETARY_SUPPLEMENT

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

Healthy individuals (camel milk)
Cow milkDIETARY_SUPPLEMENT

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

Healthy individuals (cow milk)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Milk

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Dr Nader Lessan, MBBS MD FRCP

    Imperial College London Diabetes Centre

    PRINCIPAL INVESTIGATOR

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

Locations