Hospital Regional Universitario de Málaga. Hospital Materno-Infantil.
Málaga, 29011, Spain
NCT Number: NCT05124847
The main aim of the study is to collect preliminary information on the feasibility and efficacy of a time restricted eating intervention in Spanish children and adolescents with obesity and metabolic comorbidities. Two 8-week interventions will performed in a randomized crossover controlled design: a) reduction of the habitual eating window; b) standard care. Different measurements of body composition and cardiometabolic health markers will be performed along those weeks.
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Notify Me10 year–15 year
All sexes
Interventional
Not applicable
Málaga, 29011, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2.1. Hepatic steatosis confirmed by abdominal ultrasound in the previous 12 months.
2.2. Triglycerides> 150 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.
2.3. HDL cholesterol <40 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.
2.4. LDL cholesterol> 135 mg/dl, confirmed in analytical determination in the 4 weeks prior to the start of the study.
2.5. Insulin resistance, determined by elevated HOMA-IR confirmed by analytical determination in the 4 weeks prior to the start of the study.
Exclusion criteria
Participants will receive nutritional education sessions and will be instructed to maintain an intake window of at least 13 hours a day, preferably every day of the week and in any case at least 6 days a week.
A personalized progression will be established to progressively reduce the intake window during the first 10 days of intervention. After these first 10 days, the participants will be prescribed to limit food intake to a maximum of 10 hours a day, at least 5 days a week. Participant can freely select the time of day to place the intake window. However, it will be recommended to avoid making the last intake in the 3 hours before going to bed. After 4 weeks of intervention, the dietitian will invite them to reduce the intake window to 9 or 8 hours, if they consider it feasible, maintaining this new intake window during the last 4 weeks of intervention. The intake window can be maintained at 10 hours until the end of the study.
Time frame: From week 0 to week 8
Time frame: week 8
Time frame: week 8
Time frame: week 8
Time frame: week 8
Time frame: week 8
Time frame: week 8
Time frame: From week 6 to week 8
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Other
Time Restricted Eating as a Treatment for Pediatric Obesity
Acronym: TREPO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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