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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02653378
Other study ID # H09-09-03
Secondary ID
Status Completed
Phase N/A
First received January 6, 2016
Last updated January 8, 2016
Start date November 2009
Est. completion date March 2012

Study information

Verified date January 2016
Source University of Ottawa
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Behavioral:
DIET
25% Energy Depletion by Diet only for 3 Days
EX
25% Energy Depletion by Exercise only for 3 Days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Ottawa

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Change in fasting measure of Leptin One fasting sample of plasma Leptin Day 1 and Day 4 of each study arm (DIET and EX) No
Secondary Change in fasting measure of Ghrelin 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) No
Secondary 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 Day 1 and Day 4 of each study arm (DIET and EX) No
Secondary 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 Day 1 and Day 4 of each study arm (DIET and EX) No
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