NCT01812967

Brief Summary

The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

First QC Date

March 13, 2013

Last Update Submit

March 15, 2013

Conditions

Glycemic ControlGastrointestinal Hormone ResponseHealthy Young Men

Outcome Measures

Primary Outcomes (1)

  • Glucose

    0-180 min

Secondary Outcomes (1)

  • Insulin

    0-180 min

Other Outcomes (1)

  • Gastrointestinal hormones and gastric emptying rate

    0-180 min

Interventions

Milk FatDIETARY_SUPPLEMENT
Milk ProteinDIETARY_SUPPLEMENT
LactoseDIETARY_SUPPLEMENT
Whole milk (3.25% M.F.(OTHER

Commercially available milk from the grocery store

Simulated Milk BeverageDIETARY_SUPPLEMENT

Added lactose + fat + protein together to form a mixture

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men
  • years of age
  • BMI: 20-24.9 kg/m2

You may not qualify if:

  • Smoking
  • Dieting
  • Skipping breakfast
  • Lactose intolerance or allergies to milk
  • Taking medications that may affect glucose metabolism or appetite
  • Diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

  • Panahi S, El Khoury D, Kubant R, Akhavan T, Luhovyy BL, Goff HD, Anderson GH. Mechanism of action of whole milk and its components on glycemic control in healthy young men. J Nutr Biochem. 2014 Nov;25(11):1124-1131. doi: 10.1016/j.jnutbio.2014.07.002. Epub 2014 Jul 31.

    PMID: 25167977DERIVED

MeSH Terms

Interventions

Milk ProteinsLactose

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMilkDairy ProductsFood and BeveragesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 18, 2013

Primary Completion

September 1, 2011

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

CA(1)