IndividualityPhase 4HRVNCT02768636
Can Omega-3 Improve Heart Rate Variability Measurement?
A Phase 4 study testing Omega-3 in people with Individuality, run by Vachira Phuket Hospital at 2 sites in Thailand.
Trial summary
Heart rate variability can represent physiological and psychological levels via sympathetic and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can effect on physiological and psychological with many good results. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Individuality
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesThailand
- Study dates
- Apr 2016to Jul 2016
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged group is 18-65 years old
- Understanding communication
- Normal electrocardiogram
- Allowance by their physicians
- No disturbance with their regular treatments
Who cannot join
- Abnormal bleeding tendency problems
- Non-understanding communication
- No enough time persons
- No information allowance
- Complicated illnesses conditions
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Vachira Phuket Hospital
Phuket, Phuket, 83000
Vachira Phuket
Phuket, Phuket, 83000
About this study
Heart rate variability can represent physiological and psychological levels via sympathetic and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can effect on physiological and psychological with many good results. The pathways to explain about its effect had been studied in many contexts. Effect to autonomic nervous function by Omega-3 is our interesting question.
Read the detailed description
Heart Rate Variability (HRV). HRV has two domains, time domain and frequency domain. SDNN (Standard Deviation Normal to Normal) is the first time domain. In healthy state, the signal is more diversity and SDNN is high. Decrease of SDNN means that ability to maintain homeostasis is reduced. It is shown while a person is in any disease state. Significant decreasing of HRV is an indicator for general health. PSI (Physical Stress Index) is the pressure loaded state due to overloaded physical activity and heart rate is increasing. Total power (TP), Very low frequency (VLF), Low frequency (LF), High frequency (HF), normalized Low frequency (nLF, LF norm) = LF/(LF +HF), normalized High frequency (nHF, HF norm) = HF/(LF+HF) and Low frequency to High frequency ratio (LF/HF) are frequency domain. Mean Heart rate (MHR) is also an indicator representing autonomic function.
Range of study: It will be done during April - May 2016.
Population Enrollment and recruitment was done by selected volunteers for our 100 participants.
Investigator: Training investigators were selected from psychologists, technicians, nurses, medical students and hospital health colleagues. Certified attending the class of training, assessment and evaluation was done before study.
Maneuver: Instruments were questionnaires and HRV measurements by SA-3000P. Fast Fourier Transformation method (FFT) was applied underlying it. Finger probe was used by five minutes with comfort sitting upright position. Normal respiration and not heavy pay attention in the monitor by looking to the wall. Enough sleeping in the night before study and no take coffee, drugs, alcohol or smoking two hours before study.
Variables: HRT, Heart rate; SDNN, Standard deviation of normal to normal interval; RMSSD, the square root of the mean squared differences of successive NN intervals; PSI, Physical stress index; ApEn, Approximate Entropy; SRD, Successive R-R interval difference; TSRD, Total SRD;TP, Total power; VLF, Very low frequency; LF, Low frequency; HF, High frequency; nLF, normalized LF; nHF, normalized HF.
Statistical analysis: We use descriptive study and report it in percents, means, standard deviations, medians, inter quartiles ranges. Independent t-test and ANOVA were used in parametric test. Pearson Chi-square Test, Mann-Whitney U Test, Kruskal-Wallis Test, Kolmogorov-Smirnov Z Test, Wald-Wolfowitz Test were used in nonparametric test. Significance of statistical analysis was 0.05 or 95% confidence interval. Units of SDNN is millisecond (ms) and TP, VLF, LF, HF are square of millisecond (ms2) multiply by 100. Comparative study (before and after) will use paired t-test or non-parametric (McNemar test, Sign test or Wilcoxon).
Conflict of interest: We receive these products (Omega-3, Fish oil) from Starlab company and this manufacturing will be stop to produce this agent in this April because of high business competition. They donate the remaining products for this research.
- Conditions
- Individuality
- Being tested
- Omega-3
- Keywords
- Omega-3, ANS, HRV, SDNN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called Fish oil
Omega-3 or Fish oil (1000 mg.) is taken for one capsule a day in 30 days duration. Heart rate variability is tested before at starting day and later follow up it again in the next 30 days appointment.
| Study group | Role | What they receive |
|---|---|---|
| Before and after omega-3 used | Experimental | Before and after omega-3 used Receives: Dietary Supplement: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability assessed using the SA-3000P
Comparative participants' Heart rate variability study will be done before and after 30 days treated with Omega-3. Instruments were questionnaires and HRV measurements by SA-3000P. Fast Fourier Transformation method (FFT) was applied underlying it. Finger probe was used by five minutes with comfort sitting upright position. Variables: HRT (BPM), Heart rate; SDNN (ms), Standard deviation of normal to normal interval; RMSSD (ms), the square root of the mean squared differences of successive NN intervals; PSI (No scale), Physical stress index; ApEn (No scale), Approximate Entropy; SRD (No scale), Successive R-R interval difference; TSRD (No scale), Total SRD; TP (ms^2), Total power; VLF (ms^2), Very low frequency; LF (ms^2), Low frequency; HF (ms^2), High frequency; nLF (n.u.), normalized LF; nHF (n.u.), normalized HF, LF/HF, Low frequency/ High frequency
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndividualityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vachira Phuket Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessada Chungpaibulpatana, Tappana Sumpatanarax, Vachira Phuket Hospital
- Investigators
- Jessada Chungpaibulpatana, MD., Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768636
- Sponsor's protocol ID
- VPH2016001
- Acronym
- HRV
- Status last verified
- Oct 2016
- First submitted
- 3 May 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Omega-3 Improve Heart Rate Variability Measurement?
- ClinicalTrials.gov ID
- NCT02768636
- Acronym / sponsor ID
- HRV / VPH2016001
- Conditions
- Individuality
- Keywords
- Omega-3, ANS, HRV, SDNN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vachira Phuket HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
Heart rate variability can represent physiological and psychological levels via sympathetic and parasympathetic variables on autonomic nervous function. Omega-3 has shown that it can effect on physiological and psychological with many good results. The pathways to explain about its effect had been studied in many contexts. Effect to autonomic nervous function by Omega-3 is our interesting question.
Detailed description
Heart Rate Variability (HRV). HRV has two domains, time domain and frequency domain. SDNN (Standard Deviation Normal to Normal) is the first time domain. In healthy state, the signal is more diversity and SDNN is high. Decrease of SDNN means that ability to maintain homeostasis is reduced. It is shown while a person is in any disease state. Significant decreasing of HRV is an indicator for general health. PSI (Physical Stress Index) is the pressure loaded state due to overloaded physical activity and heart rate is increasing. Total power (TP), Very low frequency (VLF), Low frequency (LF), High frequency (HF), normalized Low frequency (nLF, LF norm) = LF/(LF +HF), normalized High frequency (nHF, HF norm) = HF/(LF+HF) and Low frequency to High frequency ratio (LF/HF) are frequency domain. Mean Heart rate (MHR) is also an indicator representing autonomic function.
Range of study: It will be done during April - May 2016.
Population Enrollment and recruitment was done by selected volunteers for our 100 participants.
Investigator: Training investigators were selected from psychologists, technicians, nurses, medical students and hospital health colleagues. Certified attending the class of training, assessment and evaluation was done before study.
Maneuver: Instruments were questionnaires and HRV measurements by SA-3000P. Fast Fourier Transformation method (FFT) was applied underlying it. Finger probe was used by five minutes with comfort sitting upright position. Normal respiration and not heavy pay attention in the monitor by looking to the wall. Enough sleeping in the night before study and no take coffee, drugs, alcohol or smoking two hours before study.
Variables: HRT, Heart rate; SDNN, Standard deviation of normal to normal interval; RMSSD, the square root of the mean squared differences of successive NN intervals; PSI, Physical stress index; ApEn, Approximate Entropy; SRD, Successive R-R interval difference; TSRD, Total SRD;TP, Total power; VLF, Very low frequency; LF, Low frequency; HF, High frequency; nLF, normalized LF; nHF, normalized HF.
Statistical analysis: We use descriptive study and report it in percents, means, standard deviations, medians, inter quartiles ranges. Independent t-test and ANOVA were used in parametric test. Pearson Chi-square Test, Mann-Whitney U Test, Kruskal-Wallis Test, Kolmogorov-Smirnov Z Test, Wald-Wolfowitz Test were used in nonparametric test. Significance of statistical analysis was 0.05 or 95% confidence interval. Units of SDNN is millisecond (ms) and TP, VLF, LF, HF are square of millisecond (ms2) multiply by 100. Comparative study (before and after) will use paired t-test or non-parametric (McNemar test, Sign test or Wilcoxon).
Conflict of interest: We receive these products (Omega-3, Fish oil) from Starlab company and this manufacturing will be stop to produce this agent in this April because of high business competition. They donate the remaining products for this research.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before and after omega-3 used | Experimental | Dietary Supplement: Omega-3Before and after omega-3 used |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged group is 18-65 years old
- Understanding communication
- Normal electrocardiogram
- Allowance by their physicians
- No disturbance with their regular treatments
Key exclusion criteria (5 listed)
- Abnormal bleeding tendency problems
- Non-understanding communication
- No enough time persons
- No information allowance
- Complicated illnesses conditions
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 |
|---|---|---|
| Omega-3Also: Fish oilOmega-3 or Fish oil (1000 mg.) is taken for one capsule a day in 30 days duration. Heart rate variability is tested before at starting day and later follow up it again in the next 30 days appointment. | Dietary supplement | Before and after omega-3 used |
Primary outcome
Change in Heart Rate Variability assessed using the SA-3000P
Time frame: Baseline and 30 days
Comparative participants' Heart rate variability study will be done before and after 30 days treated with Omega-3. Instruments were questionnaires and HRV measurements by SA-3000P. Fast Fourier Transformation method (FFT) was applied underlying it. Finger probe was used by five minutes with comfort sitting upright position. Variables: HRT (BPM), Heart rate; SDNN (ms), Standard deviation of normal to normal interval; RMSSD (ms), the square root of the mean squared differences of successive NN intervals; PSI (No scale), Physical stress index; ApEn (No scale), Approximate Entropy; SRD (No scale), Successive R-R interval difference; TSRD (No scale), Total SRD; TP (ms^2), Total power; VLF (ms^2), Very low frequency; LF (ms^2), Low frequency; HF (ms^2), High frequency; nLF (n.u.), normalized LF; nHF (n.u.), normalized HF, LF/HF, Low frequency/ High frequency
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 1 Nov 2016.
- Front Physiol. 2011; 2: 84. published online 2011 Nov 16. Prepublished online 2011 Oct 4.doi: 10.3389/fphys.2011.00084 Available fromLink provided by the sponsor.
- Cicka, Danielle, "The Effect of Omega-3 Fatty Acids on Heart Rate Variability, Coronary Heart Disease, and Depression" (2013). Washington University Undergraduate Research Digest, Volume 9, Issue 1. Available fromLink provided by the sponsor.
- K. Connor, W. Zhang, V. Payne, V. Payne, L. Watkins, D. Watkins. Neuropsychopharmacology; 2005. Available fromLink provided by the sponsor.
- Dariush Mozaffarian, Phyllis K. Stein, Ronald J. Prineas, David S. Siscovick. Circulation. 2008;117:1130-1137. Available fromLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jessada Chungpaibulpatana, MD. study director
Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 in people with Individuality, run by Vachira Phuket Hospital at 2 sites in Thailand.
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 5 inclusion and 5 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Heart Rate Variability assessed using the SA-3000P (time frame: Baseline and 30 days). 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 1 Nov 2016; AzTrials last refreshed its copy on 1 Nov 2026.