ThrombosisNCT03251014
Thrombotic Effects of Yellowstripe Scad
A study testing YSS and Salmon in people with Thrombosis, run by Universiti Putra Malaysia.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- YSS and Salmon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 9 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian
- Overweight participants (BMI 23-27.4 kg/m2)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Thrombosis
- Being tested
- YSS, Salmon
- Keywords
- Thrombosis, Yellowstripe scad, Salmon, Healthy overweight subjects, Randomized crossover trial
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YSSOther
Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks
SalmonOther
Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| YSS/salmon group | Experimental | YSS followed by salmon Receives: Other: YSS; Other: Salmon |
| Salmon/YSS group | Experimental | Salmon followed by YSS Receives: Other: YSS; Other: Salmon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemostatic status assessed by immunoassay method
Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.
Measured: 8 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Changes in body mass index (BMI)
Weight and height are combined to report BMI in kg/m^2
Measured: 8 weeks
Changes in blood pressure
Seated systolic and diastolic blood pressures are taken in mmHg.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startOct 2016
- Primary completion9 May 2017
- Study completion9 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science, Technology and Innovation (MOSTI) Malaysia
- Responsible party
- Principal investigator, Dr. Loh Su Peng, Universiti Putra Malaysia
- Investigators
- Su Peng Loh, PhD, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251014
- Sponsor's protocol ID
- 06-01-04-SF2310
- Other IDs
- NMRR-16-2693-32300., FPSK(FR16)P005
- Status last verified
- Aug 2017
- First submitted
- 30 May 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thrombotic Effects of Yellowstripe Scad (YSS) Compared to Salmon Among Healthy Overweight Subjects: A Randomized Cross Over Trial
- ClinicalTrials.gov ID
- NCT03251014
- Acronym / sponsor ID
- 06-01-04-SF2310
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Yellowstripe scad, Salmon, Healthy overweight subjects, Randomized crossover trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Science, Technology and Innovation (MOSTI) Malaysia
- Study start
- Oct 2016 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YSS/salmon group | Experimental | Other: YSS, Other: SalmonYSS followed by salmon |
| Salmon/YSS group | Experimental | Other: YSS, Other: SalmonSalmon followed by YSS |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Malaysian
- Overweight participants (BMI 23-27.4 kg/m2)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YSSIntervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks | Other | Salmon/YSS group, YSS/salmon group |
| SalmonIntervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks | Other | Salmon/YSS group, YSS/salmon group |
Primary outcome
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.
5 secondary outcomes
Changes in lipid and glucose profiles analysed by medical diagnostic laboratory
Time frame: 8 weeks
Changes in liver enzymes analysed by medical diagnostic laboratory
Time frame: 8 weeks
Changes in renal function analysed by medical diagnostic laboratory
Time frame: 8 weeks
Changes in body mass index (BMI)
Time frame: 8 weeks
Changes in blood pressure
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Peng Loh, PhD principal investigator
Universiti Putra Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing YSS and Salmon in people with Thrombosis, run by Universiti Putra Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hemostatic status assessed by immunoassay method (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.