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Completed

NCT Number: NCT03251014

Thrombotic Effects of Yellowstripe Scad

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.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The project was a randomized, two-period, crossover trial with 8-week treatment periods and 8-week washout period. A total of 50 healthy overweight adults were recruited among staff and students in UPM. All the subjects were randomized into two groups. Each group was served with either cooked YSS (~265 g/ day) or salmon (~246 g/day) thrice per week. Blood and urine samples were collected for laboratory assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

YSS

Other

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

Salmon

Other

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

Primary outcomes

  1. Changes in hemostatic status assessed by immunoassay method

    Time frame: 8 weeks

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

Secondary outcomes

  1. Changes in lipid and glucose profiles analysed by medical diagnostic laboratory

    Time frame: 8 weeks

    Total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and fasting blood glucose in mmol/L are evaluated.

  2. Changes in liver enzymes analysed by medical diagnostic laboratory

    Time frame: 8 weeks

    Serum levels of alanine transaminase (ALT), aspartate transaminase (AST), alkaline Phosphatase (ALP) and gamma glutamyl transferase (GGT) in IU/L are determined.

  3. Changes in renal function analysed by medical diagnostic laboratory

    Time frame: 8 weeks

    Serum levels of creatinine, urea, and electrolytes (sodium, potassium, and chloride) in mmol/L are determined.

  4. Changes in body mass index (BMI)

    Time frame: 8 weeks

    Weight and height are combined to report BMI in kg/m^2

  5. Changes in blood pressure

    Time frame: 8 weeks

    Seated systolic and diastolic blood pressures are taken in mmHg.

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • Ministry of Science, Technology and Innovation (MOSTI) Malaysia

Registry information

Official study title

The Thrombotic Effects of Yellowstripe Scad (YSS) Compared to Salmon Among Healthy Overweight Subjects: A Randomized Cross Over Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 16, 2017
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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