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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02768636
Other study ID # VPH2016001
Secondary ID
Status Completed
Phase Phase 4
First received May 3, 2016
Last updated October 31, 2016
Start date April 2016
Est. completion date July 2016

Study information

Verified date October 2016
Source Vachira Phuket Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Ministry of Public Health
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Aged group is 18-65 years old

2. Understanding communication

3. Normal electrocardiogram

4. Allowance by their physicians

5. No disturbance with their regular treatments

Exclusion Criteria:

1. Abnormal bleeding tendency problems

2. Non-understanding communication

3. No enough time persons

4. No information allowance

5. Complicated illnesses conditions

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omega-3
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.

Locations

Country Name City State
Thailand Vachira Phuket Phuket
Thailand Vachira Phuket Hospital Phuket

Sponsors (1)

Lead Sponsor Collaborator
Vachira Phuket Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline and 30 days Yes
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