Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Dietary Supplement: Omega 3; Other: Placebo

• Registration Number: NCT06555705
• Lead Sponsor: Cairo University

Brief Summary

Evidence shows that omega-3 fatty acids lower blood triglyceride levels, lower blood pressure, enhance insulin sensitivity, and improve heart rate variability (HRV) measures, all of which may be indicators of cardiovascular health.As a result, omega-3 fatty acid supplementation may be a low-cost strategy with little adverse effects for obese youngsters, perhaps delaying the development of chronic cardiovascular illnesses.

Detailed Description

This is a two-armed study , the interventional group will be given omega 3 and the control group will be given a placebo and both will be examined for the heart rate variability

Study Timeline

• Study Start: 2024-04-03
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-15
• Primary Completion: 2024-08-25
• Study Completion: 2024-09-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children (5-12 years) whose parents or caregivers will agree to be enrolled in the study
• Obese Children (Simple obesity )
• Both males and females

Exclusion Criteria

• Patients are known to have cardiac disease
• Patients with associated chronic systemic illness
• Patients with 2ry obesity : (endocrine /metabolic/genetics/drug intake)
• Patients on medications affecting heart rate :structural or arrhythmic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months	Omega 3	The intervention group will be examined by 10 -minutes Holter and then omega 3 will be given to children( at least 400 mg eicosapentaenoic acid (EPA) and 120 mg docosahexaenoic acid (DHA) daily in addition to the standard nutritional regimen ) daily for 3 months and then reassesent of Holter will be carried out .
Control group receiving placebo and the standard nutritional regimen for 3 months	Placebo	The control group will be examined by 10 -minutes Holter and then the standard nutritional regimen will be given daily for 3 months and then reassessment of Holter will be carried out .

Primary Outcome Measures

Name	Time	Method
The effect of omega-3 on heart rate variability that is represented in the root mean square of successive differences of the heart rates ( RMSSD ) in obese children	3 months	Obese children will be examined for the effect of Omega-3 supplementation on heat rate variability

Trial Locations

Locations (1)

Hoda Atef Abdelsattar Ibrahim; 🇪🇬 Cairo, Egypt