NCT02491801

Brief Summary

The proposed study is planned to determine the potential role for regular fat dairy products in short-term metabolic control in younger and older adults and the metabolic flexibility in response to food components, which are areas that have not yet been explored. Subjects would be served with solid (cheese), semi-solid (yogurt) and liquid (milk) dairy products and skim milk (control) and water (non-caloric control) in three separate studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable type-2-diabetes-mellitus

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

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

July 2, 2015

Last Update Submit

November 2, 2020

Conditions

Type 2 Diabetes MellitusObesity

Keywords

DairyMilkYogurtCheesePostprandial glycaemiaSatietyFood IntakeElderlyPrevention and Treatment

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose (Study 1, 2 and 3)

    Blood glucose (mmol/L) is measured by using finger prick capillary blood samples. Time frame and frequency vary for each study. Study 1: Baseline measure (0 minute) then every 15 minutes up to 120 min (post-treatment), 8 times; 140 to 170 min (post-meal) every 30 mintes, 2 times . A total of 10 times Study 2: Baseline measure (0 minute) then post-treatment every 15 minutes up to 90 minutes and last measure at 120 minutes. A total of 7 times. Study 3: Part 1: Baseline measure (0 minute) then every 15 minutes up to 30 minutes post-treatment, then 50 minutes and every 15 minutes until 125 minutes. A total of 9 times. Part 2: Baseline measure (0 minute) then at 15 post-treatment and, 35 and 50 minutes post-meal. A total of 4 times

    Post-treatment and post-meal

Other Outcomes (4)

  • Gastrointestinal hormones (Study 1)

    Post-treatment and post-meal

  • Serum Insulin (Study 1 and 2)

    Post-treatment and post-meal

  • Subjective appetite (Study 1, 2 and 3)

    Post-treatment and post-meal

  • +1 more other outcomes

Study Arms (5)

3.25% M.F. Milk

EXPERIMENTAL

3.25% M.F. Milk

Other: Dietary intervention

Greek Yogurt

EXPERIMENTAL

Greek Yogurt (2% M.F.)

Other: Dietary intervention

Cheddar Cheese

EXPERIMENTAL

Regular Fat Cheddar Cheese

Other: Dietary intervention

Control 1

EXPERIMENTAL

Skim milk

Other: Dietary intervention

Control 2

EXPERIMENTAL

Filtered water, calorie-free control

Other: Dietary intervention

Interventions

Dietary interventionOTHER

All arms are given to all participants, in a randomized order

3.25% M.F. MilkCheddar CheeseControl 1Control 2Greek Yogurt

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, non-smoking male and female participants aged 20-30 and 60-70 years old
  • Young adults with body mass index (BMI) of 18.5-24.9 kg/m2 (normal weight) and older adults with BMI between 18.5-29.9 kg/m2 (normal/overweight).

You may not qualify if:

  • Diabetic
  • Individuals on medication affecting appetite
  • Lactose-intolerant or allergic to dairy (including milk, yogurt, and cheese)
  • Breakfast skippers
  • Gastrointestinal problems
  • Individuals on an energy-restricted diet

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 Mellitus, Type 2Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • G. Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 8, 2015

Study Start

March 1, 2015

Primary Completion

February 21, 2018

Study Completion

February 21, 2018

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)