OlfactionDEXDERNCT02653378
The Effects of Acute Caloric Deprivation on Odour Identification and Food Reward
A study testing DIET and EX in people with Olfaction and Diet, run by University of Ottawa.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- What is being tested?
- DIET and EX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Free from any illness that could influence outcome of the experiment
- Weight-stable for >6months
- aged between 18-40 years
Who cannot join
- diabetic
- smoker
- medication
About this study
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.
Read the 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.
- Conditions
- Olfaction, Diet, Exercise, Energy Depletion, Food Hedonics, Food Reward
- Being tested
- DIET, EX
- Medical subject headings
- Anosmia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIETBehavioural
25% Energy Depletion by Diet only for 3 Days
EXBehavioural
25% Energy Depletion by Exercise only for 3 Days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DIET |
| EX ARM | Active comparator | A 25% energy depletion (daily for 3 days) induced by performing aerobic exercise at 50% of V02max. Receives: Behavioral: EX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 and Day 4 of each study arm (DIET and EX)
Secondary outcomes (4)
Change in fasting measure of Leptin
One fasting sample of plasma Leptin
Measured: Day 1 and Day 4 of each study arm (DIET and EX)
Change in fasting measure of Ghrelin
One fasting sample of plasma Ghrelin taken at Day 1 and Day 4 of study
Measured: 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
Computer task measuring reinforcing value of preferred snack food and preferred fruit at Day 1 and Day 4 of study
Measured: Day 1 and Day 4 of each study arm (DIET and EX)
Olfaction--Odor Detection Threshold measured by Sniffin Sticks odorized pens
Measure of odour threshold for n-butanol taken at Day 1 and Day 4 of study
Measured: Day 1 and Day 4 of each study arm (DIET and EX)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startNov 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OlfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Doucet, University of Ottawa
- Investigators
- Eric Doucet, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653378
- Sponsor's protocol ID
- H09-09-03
- Acronym
- DEXDER
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28877891Cameron 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.
PubMed 26888712
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Caloric Deprivation on Odour Identification and Food Reward
- ClinicalTrials.gov ID
- NCT02653378
- Acronym / sponsor ID
- DEXDER / H09-09-03
- Conditions
- Olfaction, Diet, Exercise, Energy Depletion, Food Hedonics, Food Reward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIET ARM | Active comparator | Behavioral: DIETA 25% energy depletion (daily for 3 days) induced by reducing the amount of energy intake that would otherwise keep the individual in energy balance. |
| EX ARM | Active comparator | Behavioral: EXA 25% energy depletion (daily for 3 days) induced by performing aerobic exercise at 50% of V02max. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Free from any illness that could influence outcome of the experiment
- Weight-stable for >6months
- aged between 18-40 years
Key exclusion criteria (3 listed)
- diabetic
- smoker
- medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIET25% Energy Depletion by Diet only for 3 Days | Behavioural | DIET ARM |
| EX25% Energy Depletion by Exercise only for 3 Days | Behavioural | EX ARM |
Primary outcome
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
4 secondary outcomes
Change in fasting measure of Leptin
Time frame: 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)
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)
Olfaction--Odor Detection Threshold measured by Sniffin Sticks odorized pens
Time frame: Day 1 and Day 4 of each study arm (DIET and EX)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 28877891McNeil 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.
- Derived from this study: PubMed 26888712Cameron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Doucet, PhD principal investigator
University of Ottawa
Questions about this trial
What is this clinical trial studying?
A study testing DIET and EX in people with Olfaction and Diet, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.