Obesity, ChildhoodNCT06555705
Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children
A study testing Omega 3 in people with Obesity, Childhood, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Omega 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2024to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (5-12 years) whose parents or caregivers will agree to be enrolled in the study
- Obese Children (Simple obesity )
- Both males and females
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Childhood
- Being tested
- Placebo, Omega 3
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
The control group will be given placebo for 3 months
Omega 3Dietary supplement
The interventional group will be given omega 3 for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start3 Apr 2024
- Primary completion25 Aug 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Atef Abdelsattar Ibrahim, Cairo University
- Investigators
- Rodina Sobhy, Study director, Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555705
- Sponsor's protocol ID
- MS-547-2023
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children, a Clinical Trial
- ClinicalTrials.gov ID
- NCT06555705
- Acronym / sponsor ID
- MS-547-2023
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months | Experimental | Dietary Supplement: Omega 3The 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 . |
| Control group receiving placebo and the standard nutritional regimen for 3 months | Placebo comparator | Other: PlaceboThe 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 . |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (5-12 years) whose parents or caregivers will agree to be enrolled in the study
- Obese Children (Simple obesity )
- Both males and females
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe control group will be given placebo for 3 months | Other | Control group receiving placebo and the standard nutritional regimen for 3 months |
| Omega 3The interventional group will be given omega 3 for 3 months | Dietary supplement | Interventional group recieveing omega 3 and the standard nutritional regimen for 3 months |
Primary outcome
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
Time frame: 3 months
Obese children will be examined for the effect of Omega-3 supplementation on heat rate variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodina Sobhy study director
Professor of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 in people with Obesity, Childhood, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.