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OpenTrials
Completed

NCT Number: NCT02471092

The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood

The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph- Human Nutraceutical Research Unit

Guelph, Ontario, N1G2W1, Canada

About this study

  • A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.
  • Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 20 - 24.9 kg/m2
  • Healthy as determined by screening questionnaire
  • Male or Female
  • Non-smoking
  • Normal fasting plasma glucose (<5.5 mmol/L), but not below 3.3 mmol/L.
  • Prior use of acetaminophen

Exclusion criteria

  • Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)
  • Weight loss or weight gain of more than 5 kg during the previous 2 months
  • Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)
  • Serious medical condition (ie. Renal, liver)
  • Lack of appetite or skipping breakfast
  • Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint >16
  • Smoking
  • Reported intolerance to milk or very low consumption (< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods.
  • Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise
  • Diabetes or other metabolic diseases that could interfere with study outcomes
  • Acetaminophen, codeine or opioid allergy
  • Pregnant or Breast Feeding
  • Typical alcohol consumption of not more than 4 drinks per sitting

Treatment and study plan

Skim milk products

Other

Milk treatments will be served with 58g of breakfast cereal.

Primary outcomes

  1. Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)

    Time frame: 0-200 minutes

Secondary outcomes

  1. Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)

    Time frame: 0-200 minutes

  2. Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)

    Time frame: at 120 minutes

Other outcomes

  1. Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)

    Time frame: 0-200 minutes

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Laval University
  • University of Toronto

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
Oct 25, 2016

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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