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NCT07739095

Overview

NCT ID: NCT07739095
Lead Sponsor: University of OttawaOTHER
Official Title: Weight Loss and Hunger: Did we Get it Wrong All This Time?
Brief Summary: Weight loss is difficult and weight maintenance even worse. The principles of dieting dictate that to maintain weight loss, one has to eat less calories than they did before the diet. However, there is evidence to show that it may be the diet per se and not the weight loss that makes people more hungry and vulnerable to weight regain. This study will explore whether appetite control can be restored to normal levels through an individually tailored increase in calories after weight loss. If supported, the findings from this study could alter the way we view dieting.
Conditions: Obesity & Overweight
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Sep 1, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

18-55 years of age;

non-smoking;

obese class I-II (30 kg/m2 ≤ BMI < 40 kg/m2);

weight stable (± 2 kg during the 6 months prior to enrollment);

Sedentary (<2 times/week of 30 min of continuous exercise)

In addition, Females will be included if:

1) premenopausal (2 menses in the 3 months preceding testing, no increase in cycle irregularity in the 12 months preceding testing).

Exclusion Criteria:

have a current diagnosis of an axis 1 psychiatric disorder (i.e. mood, anxiety and eating disorders);

currently use antidepressants, thyroid medication, or any medication that could affect appetite;

have a history of cardiac problems or symptoms suggestive of any cardiac condition;

have a current diagnosis or history of diabetes, confirmed by a measure of HbA1c during the screening visit;

have alcohol intake that exceeds recommendations or alcoholism, or current addictions to opiates, cocaine or stimulants;

currently taking monoamine oxidase inhibitors, pressor agents, warfarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants;

have uncontrolled thyroid disease;

have any osteoarticular condition, or other reasons that would prevent them from achieving the proposed walking targets.

In addition, Females will be excluded if they:

are pregnant or planning to become pregnant over the course of the study;

are peri- or post-menopausal or have had surgically induced menopause.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Eric Doucet, PhDContact
edoucet@uOttawa.ca‭613-562-5800‬ ext. 4271

Similar Studies

Participant Group/Arms

High Energy FluxExperimental

After weight loss through a dietary intervention, the high flux group will remain in a state of energy balance through an increase in exercise and an increase in energy intake to pre-weight loss values.

Behavioral: Exercise

Behavioral: Dietary Intervention

Low Energy FluxPlacebo Comparator

After weight loss through a dietary intervention, the low-energy flux group will remain in energy balance but at a lower energy flux, with no changes in exercise levels and energy intake remaining lower than pre-weight-loss values.

Behavioral: Dietary Intervention