Thrombotic Effects of Yellowstripe Scad

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Other: YSS; Other: 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: YSS/salmon group; YSS followed by salmon	Other: YSS; Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks; Other: Salmon; Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks
EXPERIMENTAL: Salmon/YSS group; Salmon followed by YSS	Other: YSS; Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks; Other: Salmon; Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: Ministry of Science, Technology and Innovation (MOSTI) Malaysia
• Investigators: Principal Investigator: Su Peng Loh, PhD, Universiti Putra Malaysia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): May 9, 2017
• Study Completion (ACTUAL): May 9, 2017

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (ACTUAL): August 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Thrombosis; Yellowstripe scad; Salmon; Healthy overweight subjects; Randomized crossover trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 06-01-04-SF2310; NMRR-16-2693-32300. (REGISTRY: National Medical Research Register); FPSK(FR16)P005 (OTHER: Universiti Putra Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No