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

Cairo University (CU) logo

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

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

Trial contacts and locations

1

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Central trial contact

Hoda Atef Abelsattar Ibrahim; Nouran Khaled

Data sourced from clinicaltrials.gov

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