- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02653378
The Effects of Acute Caloric Deprivation on Odour Identification and Food Reward (DEXDER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of the current randomized controlled study were to examine how the modality of an acute 3 day isocaloric -25% energy depletion by dieting alone or by aerobic exercise alone differently impacts appetite and appetite-related hormones, ad libitum energy intake (EI), food hedonics and food reward, and olfaction. It was hypothesized that independent of modality of depletion, that relative to the control, there would be increased ad libitum feeding and food reward, improvements in smell performance, and a decline in fasting leptin and increase in fasting total ghrelin. It was also hypothesized that the increased food reward would prove to be a predictor of ad libitum EI and that relative to the depletion by aerobic exercise alone, the depletion by diet alone would produce greater compensatory increases in appetite, ad libitum EI, and food reward.
Statistics
To test for differences in body weight, plasma hormone concentrations, relative-reinforcing value of food (RRVF), and olfaction across each condition of the study, repeated measures ANOVA controlling for day 1 as a covariate was employed. Pairwise comparisons at day 4 using Sidak adjustment to account for multiple comparisons are reported when the ANOVA was significant. One way repeated measures ANOVAs with Sidak adjustments for multiple comparisons were used to test for differences in variables measured only at day 4: body composition (fat mas, %Fat, and fat free mass), appetite, palatability, and ad libitum EI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Free from any illness that could influence outcome of the experiment
- Weight-stable for >6months
- aged between 18-40 years
Exclusion Criteria:
- diabetic
- smoker
- medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: DIET ARM
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.
|
25% Energy Depletion by Diet only for 3 Days
|
|
Active Comparator: EX ARM
A 25% energy depletion (daily for 3 days) induced by performing aerobic exercise at 50% of V02max.
|
25% Energy Depletion by Exercise only for 3 Days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Ad Libitum Energy Intake at Buffet Lunch--total kcals consumed at lunch meal measured to nearest 0.5grams.
Time Frame: Day 1 and Day 4 of each study arm (DIET and EX)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fasting measure of Leptin
Time Frame: Day 1 and Day 4 of each study arm (DIET and EX)
|
One fasting sample of plasma Leptin
|
Day 1 and Day 4 of each study arm (DIET and EX)
|
|
Change in fasting measure of Ghrelin
Time Frame: Day 1 and Day 4 of each study arm (DIET and EX)
|
One fasting sample of plasma Ghrelin taken at Day 1 and Day 4 of study
|
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
Time Frame: Day 1 and Day 4 of each study arm (DIET and EX)
|
Computer task measuring reinforcing value of preferred snack food and preferred fruit at Day 1 and Day 4 of study
|
Day 1 and Day 4 of each study arm (DIET and EX)
|
|
Olfaction--Odor Detection Threshold measured by Sniffin Sticks odorized pens
Time Frame: Day 1 and Day 4 of each study arm (DIET and EX)
|
Measure of odour threshold for n-butanol taken at Day 1 and Day 4 of study
|
Day 1 and Day 4 of each study arm (DIET and EX)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Doucet, PhD, University of Ottawa
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H09-09-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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