Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT05184361
Eligibility Criteria:
Inclusion Criteria:
* Women
* BMI ranging between 30 and 39.9 kg/m2
* Age between 20-45 years
* Weight stable in the last 6 months (less than 5% weigh variation)
* Inactive (less then 150 min/week of moderate physical activity or 75 min/week of vigorous physical activity
* Living in Lisbon Metropolitan Area and being able to drive to Faculty of Human Kinetics and Germano de Sousa Laboratory (Algés)
* Available to be randomized to any of the trial groups (CER or IER)
* Willing to commit with the assigned group protocol, including the nutritional intervention and lifestyle recommendations, as well as being available for participation in all evaluation moments.
Exclusion Criteria:
* Previous or present health disorders: cancer, autoimmune, cardiac, psychiatric, kidney and liver disease (except liver steatosis), diabetes, chronic intestinal inflammatory disease, or other medical conditions known to affect energy balance homeostasis
* Menopause
* Hormonal or thyroid disorder
* Medications that promote weight gain or alter energy balance, including corticosteroids, antidepressants, anxiolytics, mood-stabilizing, and antipsychotics
* Medications or dietary supplements for weight-loss in the past 3 months
* Pregnant for the past 6 months or breastfeeding
* Planning to get pregnant in the next 2 years or getting pregnant during the study
* Current consumption of more than 14 alcoholic drinks per week or other substance abuse, and/or current acute treatment or rehabilitation program for alcohol/substance abuse
* Surgery or in hospital admission for the last month
* Positive for Covid-19 in the past 3 months or testing positive during the intervention phase of the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT05184361
Study Brief:
Protocol Section:
NCT05184361