Can Omega-3 Improve Heart Rate Variability Measurement? (HRV)

V

Vachira Phuket Hospital

Status and phase

Completed
Phase 4

Conditions

Individuality

Treatments

Dietary Supplement: Omega-3

Study type

Interventional

Funder types

Other

Identifiers

NCT02768636
VPH2016001

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged group is 18-65 years old Understanding communication Normal electrocardiogram Allowance by their physicians No disturbance with their regular treatments

Exclusion criteria

Abnormal bleeding tendency problems Non-understanding communication No enough time persons No information allowance Complicated illnesses conditions

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Before and after omega-3 used
Experimental group
Description:
Before and after omega-3 used
Treatment:
Dietary Supplement: Omega-3

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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