NCT01595919

Brief Summary

The objective of the current study is to determine the effects of an ad libitum intake of 1% milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that 1% milk will reduce food intake and result in better post-meal glycemic response compared to the other beverages.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable obesity

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

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

May 8, 2012

Last Update Submit

June 14, 2012

Conditions

ObesityHyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Food Intake

    Measurement of energy intake during an ad libitum test meal

    2 hours

Study Arms (5)

1% Milk

EXPERIMENTAL
Other: Nutritional Intervention

Regular Cola

EXPERIMENTAL
Other: Nutritional Intervention

Diet cola

EXPERIMENTAL
Other: Nutritional Intervention

Orange juice

EXPERIMENTAL
Other: Nutritional Intervention

Water

PLACEBO COMPARATOR
Other: Nutritional Intervention

Interventions

Nutritional InterventionOTHER

Ad libitum amounts of beverage at a meal

1% MilkDiet colaOrange juiceRegular ColaWater

Eligibility Criteria

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

You may qualify if:

  • healthy men and women
  • age 20-30 years
  • BMI between 20-24.9 kg/m\^2

You may not qualify if:

  • breakfast skippers
  • diabetes or any metabolic diseases
  • lactose intolerance or allergies to milk
  • taking medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto, Department of Nutritional Sciences

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

  • El Khoury D, Panahi S, Luhovyy BL, Douglas Goff H, Harvey Anderson G. Interaction of mealtime ad libitum beverage and food intake with meal advancement in healthy young men and women. Physiol Behav. 2015 May 1;143:39-44. doi: 10.1016/j.physbeh.2015.02.023. Epub 2015 Feb 18.

    PMID: 25700893DERIVED

MeSH Terms

Conditions

ObesityHyperglycemia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 10, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

CA(1)