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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471092
• Other study ID #: 14JN004
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: October 24, 2016
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperglycemia
• Lack of Satiety

Intervention

Other:
• Skim milk products
Milk treatments will be served with 58g of breakfast cereal.

Locations

Country	Name	City	State
Canada	University of Guelph- Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph	Laval University, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)		0-200 minutes	No
Primary	Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)		0-200 minutes	No
Secondary	Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)		0-200 minutes	No
Secondary	Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)		at 120 minutes	No