Thrombotic Effects of Yellowstripe Scad

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251014
• Other study ID #: 06-01-04-SF2310
• Secondary ID: NMRR-16-2693-323
• Status: Completed
• Phase: N/A
• First received: May 30, 2017
• Last updated: August 14, 2017
• Start date: October 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: August 2017
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Other:
• YSS
Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks
• Salmon
Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	Ministry of Science, Technology and Innovation (MOSTI) Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Changes in body mass index (BMI)	Weight and height are combined to report BMI in kg/m^2	8 weeks
Secondary	Changes in blood pressure	Seated systolic and diastolic blood pressures are taken in mmHg.	8 weeks