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OpenTrials
Completed

NCT Number: NCT01812967

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

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.

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Key information

Conditions

Glycemic Control Gastrointestinal Hormone Response Healthy Young Men

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

milk fat

Dietary Supplement

Milk protein

Dietary Supplement

Lactose

Dietary Supplement

Whole milk (3.25% M.F.(

Other

Commercially available milk from the grocery store

Simulated Milk Beverage

Dietary Supplement

Added lactose + fat + protein together to form a mixture

Primary outcomes

  1. Glucose

    Time frame: 0-180 min

Secondary outcomes

  1. Insulin

    Time frame: 0-180 min

Other outcomes

  1. Gastrointestinal hormones and gastric emptying rate

    Time frame: 0-180 min

    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.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Primary completion
2011
First posted
Mar 18, 2013
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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