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

Cairo University (CU)

Status: Enrolling

Conditions: Obesity, Childhood

Treatments: Dietary Supplement: Omega 3; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06555705

MS-547-2023

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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 .

Treatment:

Dietary Supplement: Omega 3

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

Placebo Comparator group

Description:

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 .

Treatment:

Other: Placebo