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Clinical Trials/NCT02471092
NCT02471092CompletedNot Applicable

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

University of Guelph1 site in 1 country32 target enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •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

Arms & Interventions

Skim Milk

Active Comparator

Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.

Intervention: Skim milk products (Other)

High Protein Milk

Experimental

Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.

Intervention: Skim milk products (Other)

High Protein Milk (Modified Ratio)

Experimental

Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.

Intervention: Skim milk products (Other)

Water Control

Placebo Comparator

Skim milk products. Water and permeate control; 250mL serving.

Intervention: Skim milk products (Other)

Skim Milk (Modified Ratio)

Experimental

Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.

Intervention: Skim milk products (Other)

Outcomes

Primary Outcomes

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

Time Frame: 0-200 minutes

Secondary Outcomes

  • Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)(0-200 minutes)
  • Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)(at 120 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amanda Wright, Ph.D.

Associate Professor

University of Guelph

Study Sites (1)

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