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

NCT ID: NCT06555705

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2024-09-03

Brief Summary

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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

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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

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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 .

Group Type EXPERIMENTAL

Omega 3

Intervention Type DIETARY_SUPPLEMENT

The interventional group will be given omega 3 for 3 months

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 .

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The control group will be given placebo for 3 months

Interventions

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Placebo

The control group will be given placebo for 3 months

Intervention Type OTHER

Omega 3

The interventional group will be given omega 3 for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hoda Atef Abdelsattar Ibrahim

Lectuere of Pediatrics and Pediatric Clinical Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodina Sobhy

Role: STUDY_DIRECTOR

Professor of Pediatrics

Locations

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Hoda Atef Abdelsattar Ibrahim

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-547-2023

Identifier Type: -

Identifier Source: org_study_id

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