NCT02491814

Brief Summary

This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt beverage) and non-dairy alternatives (almond and soy beverages) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

May 27, 2015

Last Update Submit

May 10, 2016

Conditions

Keywords

DairyBreakfast cerealPostprandial GlycemiaSatietyFood IntakeMilkYogurtSoyAlmond

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose

    Blood glucose (mmol/L) is measured using finger prick capillary blood samples

    0-170 minutes

  • Subjective Appetite

    Subjective appetite ratings are obtained from four 100 mm visual analogue scale (VAS) questions assessing "Desire to Eat", "Hunger", "Fullness" and "Prospective Food Consumption". The average of all four VAS is calculated to obtain the average appetite score for statistical analysis

    0-170 minutes

Secondary Outcomes (2)

  • Insulin

    0-170 minutes

  • Food Intake

    120-140 minutes

Study Arms (5)

1% M.F. Milk and Breakfast Cereal

EXPERIMENTAL

Breakfast meal: 250 ml 1% M.F. Milk, 54 g Cheerios breakfast cereal, 100 mL water

Other: 1% M.F. MilkOther: Breakfast cereal

Yogurt Beverage and Breakfast Cereal

EXPERIMENTAL

Breakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water

Other: Yogurt BeverageOther: Breakfast cereal

Soy Beverage and Breakfast Cereal

EXPERIMENTAL

Breakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water

Other: Soy BeverageOther: Breakfast cereal

Almond Beverage and Breakfast Cereal

EXPERIMENTAL

Breakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water

Other: Almond BeverageOther: Breakfast cereal

Water (control) and Breakfast Cereal

EXPERIMENTAL

Breakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water

Other: WaterOther: Breakfast cereal

Interventions

Also known as: 1% cow's milk, Neilsen Canada
1% M.F. Milk and Breakfast Cereal
Also known as: Yop (Vanilla), General Mills
Yogurt Beverage and Breakfast Cereal
Also known as: Soy Milk, Silk Organic Original
Soy Beverage and Breakfast Cereal
Also known as: Almond Milk, Silk Original
Almond Beverage and Breakfast Cereal
WaterOTHER
Also known as: Calorie-free control
Water (control) and Breakfast Cereal
Also known as: Cheerios, General Mills
1% M.F. Milk and Breakfast CerealAlmond Beverage and Breakfast CerealSoy Beverage and Breakfast CerealWater (control) and Breakfast CerealYogurt Beverage and Breakfast Cereal

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy BMI (20.0 - 24.9 kg/m2)
  • Females with regular monthly menstrual cycles

You may not qualify if:

  • Diabetes
  • Fasting blood glucose higher than 5.8 mmol/L
  • Pregnancy
  • Medications
  • Smoking
  • Lactose intolerance or allergies to milk, soy, or almonds
  • Elite athletes
  • Those trying to lose or gain weight
  • Breakfast skippers and those on an energy-restricted diet
  • Score equal to or higher than 11 on Eating Habits Questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, FitzGerald Building

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusObesity

Interventions

MilkSoy MilkWater

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesMilk SubstitutesSoy FoodsVegetable ProductsVegetablesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • G. Harvey Anderson, Ph.D.

    Department of Nutritional Sciences, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2015

First Posted

July 8, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations