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

Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children, a Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Dietary supplement: Omega 3; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Hoda Atef Abdelsattar Ibrahim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months; 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 .	Dietary supplement: Omega 3; The interventional group will be given omega 3 for 3 months
Placebo Comparator: Control group receiving placebo and the standard nutritional regimen for 3 months; 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 .	Other: Placebo; The control group will be given placebo for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Obese children will be examined for the effect of Omega-3 supplementation on heat rate variability	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Rodina Sobhy, Professor of Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): August 25, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: MS-547-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Throughout the study, the privacy and confidentiality of the data will be perceived, the results will be presented anonymously without disclosure of patients' personal identifying information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No