NCT02653378

Brief Summary

The purpose of this study is to determine how the modality of energy depletion can differently impact appetite hormones, ad libitum food intake, food hedonics, and olfaction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

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

November 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

January 6, 2016

Last Update Submit

January 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Ad Libitum Energy Intake at Buffet Lunch--total kcals consumed at lunch meal measured to nearest 0.5grams.

    Ad libitum measure of energy intake at lunch time at Day 1 and Day 4 of study

    Day 1 and Day 4 of each study arm (DIET and EX)

Secondary Outcomes (4)

  • Change in fasting measure of Leptin

    Day 1 and Day 4 of each study arm (DIET and EX)

  • Change in fasting measure of Ghrelin

    Day 1 and Day 4 of each study arm (DIET and EX)

  • Change in Relative-Reinforcing Value of Food as measured by food points earned during a computerized behavioral choice tast

    Day 1 and Day 4 of each study arm (DIET and EX)

  • Olfaction--Odor Detection Threshold measured by Sniffin Sticks odorized pens

    Day 1 and Day 4 of each study arm (DIET and EX)

Study Arms (2)

DIET ARM

ACTIVE COMPARATOR

A 25% energy depletion (daily for 3 days) induced by reducing the amount of energy intake that would otherwise keep the individual in energy balance.

Behavioral: DIET

EX ARM

ACTIVE COMPARATOR

A 25% energy depletion (daily for 3 days) induced by performing aerobic exercise at 50% of V02max.

Behavioral: EX

Interventions

DIETBEHAVIORAL

25% Energy Depletion by Diet only for 3 Days

DIET ARM
EXBEHAVIORAL

25% Energy Depletion by Exercise only for 3 Days

EX ARM

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Free from any illness that could influence outcome of the experiment
  • Weight-stable for \>6months
  • aged between 18-40 years

You may not qualify if:

  • diabetic
  • smoker
  • medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • McNeil J, Lamothe G, Cameron JD, Riou ME, Cadieux S, Lafreniere J, Goldfield G, Willbond S, Prud'homme D, Doucet E. Investigating predictors of eating: is resting metabolic rate really the strongest proxy of energy intake? Am J Clin Nutr. 2017 Nov;106(5):1206-1212. doi: 10.3945/ajcn.117.153718. Epub 2017 Sep 6.

  • Cameron JD, Goldfield GS, Riou ME, Finlayson GS, Blundell JE, Doucet E. Energy depletion by diet or aerobic exercise alone: impact of energy deficit modality on appetite parameters. Am J Clin Nutr. 2016 Apr;103(4):1008-16. doi: 10.3945/ajcn.115.115584. Epub 2016 Feb 17.

MeSH Terms

Conditions

AnosmiaMotor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric Doucet, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Kinetics

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 12, 2016

Study Start

November 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 12, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share