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

NCT06555705 | Completed

• 1 other identifier: MS-547-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months

EXPERIMENTAL

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

Control group receiving placebo and the standard nutritional regimen for 3 months

PLACEBO COMPARATOR

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

Interventions

Placebo OTHER

The control group will be given placebo for 3 months

Control group receiving placebo and the standard nutritional regimen for 3 months

Omega 3 DIETARY_SUPPLEMENT

The interventional group will be given omega 3 for 3 months

Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hoda Atef Abdelsattar Ibrahim

Cairo, Egypt

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Rodina Sobhy

  Professor of Pediatrics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lectuere of Pediatrics and Pediatric Clinical Nutrition

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 15, 2024
• Study Start: April 3, 2024
• Primary Completion: August 25, 2024
• Study Completion: September 3, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)