Thrombotic Effects of Yellowstripe Scad

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Thrombosis

Intervention / Treatment
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* Other: YSS
* Other: Salmon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YSS/salmon group<br>YSS followed by salmon | Other: YSS<br>* Intervention providing steamed whole YSS ( 265 g/day, 3 days/week) for eight weeks<br>Other: Salmon<br>* Intervention providing steamed salmon fillet ( 246 g/day, 3 days/week) for eight weeks<br>|
| Experimental: Salmon/YSS group<br>Salmon followed by YSS | Other: YSS<br>* Intervention providing steamed whole YSS ( 265 g/day, 3 days/week) for eight weeks<br>Other: Salmon<br>* Intervention providing steamed salmon fillet ( 246 g/day, 3 days/week) for eight weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid and glucose profiles analysed by medical diagnostic laboratory | Total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and fasting blood glucose in mmol/L are evaluated. | 8 weeks | 
| Changes in liver enzymes analysed by medical diagnostic laboratory | Serum levels of alanine transaminase (ALT), aspartate transaminase (AST), alkaline Phosphatase (ALP) and gamma glutamyl transferase (GGT) in IU/L are determined. | 8 weeks | 
| Changes in renal function analysed by medical diagnostic laboratory | Serum levels of creatinine, urea, and electrolytes (sodium, potassium, and chloride) in mmol/L are determined. | 8 weeks | 
| Changes in body mass index (BMI) | Weight and height are combined to report BMI in kg/m^2 | 8 weeks | 
| Changes in blood pressure | Seated systolic and diastolic blood pressures are taken in mmHg. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombosis, Yellowstripe scad, Salmon, Healthy overweight subjects, Randomized crossover trial