NCT05919667

Brief Summary

The purpose of this study is to compare the acute effects of a single serving of dairy and non-dairy alternatives on post-treatment and post-meal glycemia, appetite, plasma amino acid concentrations, and gastrointestinal hormones levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

February 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

February 28, 2022

Last Update Submit

June 22, 2023

Conditions

Keywords

DairyPost-prandial glycemiaAppetiteSatietyGut Hormone Responses

Outcome Measures

Primary Outcomes (1)

  • Change in blood glucose level

    Venous blood collection via catheter

    Starting at the beginning of each sessions (0 min, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 9 times.

Secondary Outcomes (3)

  • Subjective appetite

    Measured every 15-30 minutes up to 160 minutes]. A total of 9 times.

  • Change in plasma metabolic and gut hormones (insulin, c-peptide, glucagon-like 1 receptor, glucagon-like 2 peptide and gastric inhibitory polypeptide)

    Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 7 times.

  • Change in plasma amino acid concentrations

    Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 7 times.

Study Arms (5)

Dairy-based Product 1

EXPERIMENTAL

2% Cow's milk (Neilson, St-Laurent, Quebec)

Dietary Supplement: Dairy and plant-based dairy beverages and solids

Dairy-based Product 2

EXPERIMENTAL

Regular fat cheddar cheese (Armstrong, St-Laurent, Québec)

Dietary Supplement: Dairy and plant-based dairy beverages and solids

Plant-based Product 3:

EXPERIMENTAL

Vanilla Soy Beverage (Silk, Broomfield, Colorado)

Dietary Supplement: Dairy and plant-based dairy beverages and solids

Plant-based Product 4

EXPERIMENTAL

Vanilla Almond Beverage (Earth's Own, Vancouver, British Columbia)

Dietary Supplement: Dairy and plant-based dairy beverages and solids

Plant-based Product 5

EXPERIMENTAL

Plant-based Cheddar-Style Block (President' Choice, Brampton, Ontario)

Dietary Supplement: Dairy and plant-based dairy beverages and solids

Interventions

Crossover design: participants received all treatment arms in a randomized order

Dairy-based Product 1Dairy-based Product 2Plant-based Product 3:Plant-based Product 4Plant-based Product 5

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: ≥18.5 kg/m2 and ≤ 24.5 kg/m2'
  • Fasting serum glucose: ≤ 5.5 mmol/L
  • Frequent breakfast consumers
  • Willing to maintain habitual diet, physical activity pattern, dietary supplement routine, and body weight throughout the trial
  • Willing to abstain from alcohol consumption for 24 h prior to all test visits.
  • Willing to avoid vigorous physical activity for 24 h prior to all test visits.
  • Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

You may not qualify if:

  • Fasting blood glucose \> 5.5 mmol/L
  • Smoking tobacco products and marijuana regularly
  • Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
  • Presence of gastrointestinal disorder or surgeries within the past year
  • Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose, appetite and/or any other outcomes of the study as per investigator's judgment
  • Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months
  • Irregular menstrual cycles (i.e., frequent missed cycles), menopausal or post- menopausal
  • Breakfast skippers
  • Currently trying to lose or gain weight and any weight gain or loss of at least 10 lbs in previous three months
  • Known intolerance, sensitivity or allergy to dairy products (including milk and cheese)
  • Consumption of powders/protein supplements
  • Extreme dietary habits
  • Excessive alcohol intake
  • Restrained Eaters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences, C. David Naylor Building

Toronto, Ontario, M5S 3H2, Canada

Location

Related Publications (1)

  • Da Silva N, Anderson G, Amr A, Vien S, Fabek H. A comparison of the effects of dairy products with their plant-based alternatives on metabolic responses in healthy young Canadian adults: a randomized crossover study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-17. doi: 10.1139/apnm-2024-0158.

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

Polymethyl Methacrylate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethylmethacrylatesPolymethacrylic AcidsAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAcrylic ResinsResins, SyntheticPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • G. Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomized, single-blinded
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2022

First Posted

June 26, 2023

Study Start

February 28, 2022

Primary Completion

February 28, 2022

Study Completion

March 31, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations