Thrombotic Effects of Yellowstripe Scad

Not Applicable

Completed

• Conditions: Thrombosis
• Interventions: Other: YSS; Other: Salmon

• Registration Number: NCT03251014
• Lead Sponsor: Universiti Putra Malaysia

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Study First Submitted: 2017-05-30
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-14
• Last Update Submitted: 2017-08-14
• Study First Posted: 2017-08-16
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
YSS/salmon group	YSS	YSS followed by salmon
Salmon/YSS group	Salmon	Salmon followed by YSS
YSS/salmon group	Salmon	YSS followed by salmon
Salmon/YSS group	YSS	Salmon followed by YSS

Primary Outcome Measures

Name	Time	Method
Changes in hemostatic status assessed by immunoassay method	8 weeks	Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.

Secondary Outcome Measures

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