NCT02382471

Brief Summary

The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

February 16, 2015

Last Update Submit

March 2, 2015

Conditions

Cardiovascular Disease

Keywords

atheroscleroticBDNFFollistatinIrisin

Outcome Measures

Primary Outcomes (4)

  • Serum Irisin

    Change from baseline at 2 months

  • Serum Brain-Derived Neurotrophic Factor(BDNF)

    Change from baseline at 2 months

  • Serum Follistatin

    Change frome baseline at 2 months

  • Serum Myostatin

    Change from baseline at 2 months

Secondary Outcomes (1)

  • Serum high-sensitivity C-reactive protein (hsCRP)

    Change from baseline at 2 months

Study Arms (2)

CVD, Placebo

PLACEBO COMPARATOR

patients with cardiovascular disease who receive 4 cap of placebo/day

Dietary Supplement: Placebo

CVD, Omega-3

ACTIVE COMPARATOR

patients with Cardiovascular disease who receive 4g/d omega-3

Dietary Supplement: Omega-3

Interventions

Omega-3DIETARY_SUPPLEMENT

4 cap 1 g Omega-3 per day for 2 months

Also known as: n-3 fatty acids, n-3 PUFA
CVD, Omega-3
PlaceboDIETARY_SUPPLEMENT

4 cap 1 g Placebo(paraffin) per day for 2 months

CVD, Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiovascular disease patients 45- 65 years old,
  • patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated,
  • body mass index in the range 18.5- 35,
  • avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention,
  • willingness to participation,

You may not qualify if:

  • people who have used omega 3 supplements in last 3 months,
  • having chronic renal disease ,
  • GI disease,
  • hepatobiliary diseases,
  • hematological disorders,
  • movement disorders,
  • myopathy ,
  • hypo- or hyperthyroidism,
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Docosahexaenoic AcidsFatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Mohammad Hasan Javanbakht, MD, Ph.D

    Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 6, 2015

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

IR(1)