NCT03251014

Brief Summary

The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic effects and the effects may be similar with salmon.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

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

October 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

May 30, 2017

Last Update Submit

August 14, 2017

Conditions

Thrombosis

Keywords

ThrombosisYellowstripe scadSalmonHealthy overweight subjectsRandomized crossover trial

Outcome Measures

Primary Outcomes (1)

  • Changes in hemostatic status assessed by immunoassay method

    Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.

    8 weeks

Secondary Outcomes (5)

  • Changes in lipid and glucose profiles analysed by medical diagnostic laboratory

    8 weeks

  • Changes in liver enzymes analysed by medical diagnostic laboratory

    8 weeks

  • Changes in renal function analysed by medical diagnostic laboratory

    8 weeks

  • Changes in body mass index (BMI)

    8 weeks

  • Changes in blood pressure

    8 weeks

Study Arms (2)

YSS/salmon group

EXPERIMENTAL

YSS followed by salmon

Other: YSSOther: Salmon

Salmon/YSS group

EXPERIMENTAL

Salmon followed by YSS

Other: YSSOther: Salmon

Interventions

YSSOTHER

Intervention providing steamed whole YSS (\~265 g/day, 3 days/week) for eight weeks

Salmon/YSS groupYSS/salmon group
SalmonOTHER

Intervention providing steamed salmon fillet (\~246 g/day, 3 days/week) for eight weeks

Salmon/YSS groupYSS/salmon group

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Malaysian
  • Overweight participants (BMI 23-27.4 kg/m2)

You may not qualify if:

  • Regular use of fish oil supplements during the last one month
  • Regular consumption of fish twice or more per week
  • Vegetarian who excluded all meat, fish, and poultry from their diet
  • Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease, diabetes mellitus, hypertension, or other significant medical history that may prohibits the participation
  • Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood pressure, and inflammation
  • Women who are menopause, pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Su Peng Loh, PhD

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2017

First Posted

August 16, 2017

Study Start

October 1, 2016

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share