Time-Restricted Feeding in Children and Adolescents With Obesity

Obesity, Childhood Clinical Trial

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Official title:

Time-Restricted Feeding in Children and Adolescents With Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05174871
• Other study ID #: PIC-130-21
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of a 2-month time-restricted feeding (TRF) intervention in children and adolescents with obesity. The investigators will determine whether the potential beneficial effects of the intervention in this population are maintained over time. Furthermore, potential mechanisms mediating TRF effects will be explored, specifically focusing on the potential role of the gut microbiome and the circadian rhythm.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Obesity (BMI z score > 2)

Exclusion Criteria:

• Bariatric surgery

• Spontaneous time-restricted feeding for > 12 hours

• Diabetes with insulin treatment

• Pregnancy

• Intellectual disability

• Under drug treatment with a prescription change in the last 3 months

Related Conditions & MeSH terms

• Obesity
• Obesity, Adolescent
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Lifestyle intervention
Lifestyle intervention (usual treatment for patients with obesity). The behavioral intervention will last for 2 months.
• TRF intervention
Food intake restricted to 8 hours per day during the window between 10h and 22h. Time restricted feeding will take place 6 days per week, with the seventh day unrestricted. The intervention will last for 2 months.

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gut microbiota	Fecal samples will be obtained at every time-point and gut microbiota composition analyzed.	Baseline, 2 months, 1 year, 2 year
Other	Change in circadian rhythm	The circadian rhythm will be measured with an ActTrust actigraph (Condor Instruments) that participants will wear for 2 weeks before each time point.	Baseline, 2 months, 1 year, 2 year
Primary	Change in BMI z score	Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.	Baseline, 2 months
Secondary	Change in BMI z score (follow-up)	Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.	1 year, 2 year
Secondary	Change in Adiposity	Adiposity will be measured by bioimpedance	Baseline, 2 months, 1 year, 2 year
Secondary	Change in glucose metabolism	Fasting blood test will performed at each time point to analyze glucose metabolism, including glucose, HbA1c, and insulin levels.	Baseline, 2 months, 1 year, 2 year
Secondary	Change in lipid profile	Fasting blood test will performed at each time point to analyze the lipid profile, including triglycerides, total cholesterol, LDL-cholesterol, and HDL-cholesterol.	Baseline, 2 months, 1 year, 2 year
Secondary	Change in blood pressure	Both systolic and diastolic blood pressure will be measure at every time point	Baseline, 2 months, 1 year, 2 year
Secondary	Change in dietary composition	A 4-day food registry will be analyzed at every time point to determine daily energy, macronutrient and micronutrient intake.	Baseline, 2 months, 1 year, 2 year