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Can Omega-3 Improve Heart Rate Variability Measurement?

NCT ID: NCT02768636

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Individuality

Keywords

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Omega-3, ANS, HRV, SDNN

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Before and after omega-3 used

Before and after omega-3 used

Group Type EXPERIMENTAL

Omega-3

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fish oil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vachira Phuket Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jessada Chungpaibulpatana, Tappana Sumpatanarax

Director, Principal investigator; Co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessada Chungpaibulpatana, MD.

Role: STUDY_DIRECTOR

Director

Locations

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Vachira Phuket Hospital

Phuket, Phuket, Thailand

Site Status

Vachira Phuket

Phuket, Phuket, Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.fac.org.ar/tcvc/llave/c243/deligian.PDF

Asterios P. Deligiannis. The Effects of Exercise Training on Cardiac Autonomic Nervous Activity. Available from

http://circ.ahajournals.org/cgi/doi/10.1161/hc4201.097834

Carney RM, Blumenthal J a., Stein PK, Watkins L, Catellier D, Berkman LF, et al. Depression, Heart Rate Variability, and Acute Myocardial Infarction. Circulation \[Internet\]. 2001 Oct 23 \[cited 2014 Oct 6\];104(17):2024-8. Available from

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217222/

Front Physiol. 2011; 2: 84. published online 2011 Nov 16. Prepublished online 2011 Oct 4.doi: 10.3389/fphys.2011.00084 Available from

http://openscholarship.wustl.edu/vol9_iss1/25

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 from

http://www.nordicnaturals.com/images/researchImages/Connor_DukeABSTRACT.pdf

K. Connor, W. Zhang, V. Payne, V. Payne, L. Watkins, D. Watkins. Neuropsychopharmacology; 2005. Available from

Other Identifiers

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VPH2016001

Identifier Type: -

Identifier Source: org_study_id