NCT02768636

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

May 3, 2016

Last Update Submit

October 31, 2016

Conditions

Individuality

Keywords

Omega-3, ANS, HRV, SDNN

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Before and after omega-3 used

EXPERIMENTAL

Before and after omega-3 used

Dietary Supplement: Omega-3

Interventions

Omega-3DIETARY_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.

Also known as: Fish oil
Before and after omega-3 used

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vachira Phuket Hospital

Phuket, Phuket, 83000, Thailand

Location

Vachira Phuket

Phuket, Phuket, 83000, Thailand

Location

Related Links

MeSH Terms

Interventions

Docosahexaenoic AcidsFish Oils

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOils

Study Officials

  • Jessada Chungpaibulpatana, MD.

    Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Principal investigator; Co-investigator

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 11, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)