Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men

Glycemic Control Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812967
• Other study ID #: Milk Components Study
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: March 15, 2013

Study information

• Verified date: March 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University of Toronto Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy young men

• 20-30 years of age

• BMI: 20-24.9 kg/m2

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastrointestinal Hormone Response
• Glycemic Control
• Healthy Young Men

Intervention

Dietary Supplement:
• Milk Fat

• Milk Protein

• Lactose

Other:
• Whole milk (3.25% M.F.(
Commercially available milk from the grocery store

Dietary Supplement:
• Simulated Milk Beverage
Added lactose + fat + protein together to form a mixture

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastrointestinal hormones and gastric emptying rate	Gatrointestinal hormones measured include plasma concentrations of glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), cholecystokinin (CCK), and ghrelin.; Gastric emptying is assessed indirectly by adding 1.5 g of paracetamol (acetaminophen) to each beverage and measuring plasma paracetamol concentrations.	0-180 min	No
Primary	Glucose		0-180 min	No
Secondary	Insulin		0-180 min	No