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Dietary Supplement
Salmon Peptide Supplement for Metabolic Syndrome (SPF1 Trial)
N/A
Waitlist Available
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet at least one of the following criteria: Plasma TG > 1.35 mmol/L, Fasting glycemia ≥ 5.6 mmol/L and ≤ 6.9 mmol/L, HbA1c ≥ 5.7% and ≤ 6.4%, Insulin concentration > 42 pmol/L
Be older than 18 years old
Must not have
Suffering from any metabolic disorder requiring pharmacological treatment
>5% weight loss over the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between the beginning and th end of the intervention (6 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and effects of two doses of salmon peptide fraction on metabolic syndrome risk factors in overweight-obese men and women.
Who is the study for?
This trial is for overweight-obese men and women with a waist size of at least 94 cm for men or 80 cm for women. They must have certain metabolic syndrome risk factors like high triglycerides, blood sugar, HbA1c, or insulin levels but can't be on any related medications. No recent weight loss, surgery, or use of supplements affecting metabolism is allowed.
What is being tested?
The study tests the safety and effects on cardiometabolic health of two doses (7.5g and 15g) of salmon peptide fraction in participants with metabolic syndrome. It uses advanced biological analysis to understand how these supplements might work.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions due to fish/seafood ingredients in the supplement or gastrointestinal discomfort as commonly seen with dietary supplements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show high triglycerides, blood sugar, HbA1c, or insulin levels.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on medication for a metabolic disorder.
Select...
I have lost more than 5% of my weight in the last 3 months.
Select...
I am taking medication that affects my blood sugar or cholesterol levels.
Select...
I have not had major surgery in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between the beginning and th end of the intervention (6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between the beginning and th end of the intervention (6 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse event and general acceptability evaluated by questionnaires
Change in complete blood count using blood sampling
Change in hepatic enzymes using blood sampling
+1 moreSecondary study objectives
Change in blood pressure
Change in body mass index
Change in glucose metabolism
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SPFExperimental Treatment2 Interventions
Salmon peptide fraction supplement: powder mixed in water
Group II: ComparatorActive Control2 Interventions
Casein peptide fraction supplement: powder mixed in water
Find a Location
Who is running the clinical trial?
Laval UniversityLead Sponsor
430 Previous Clinical Trials
178,342 Total Patients Enrolled
26 Trials studying Metabolic Syndrome
1,962 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication for a metabolic disorder.I have lost more than 5% of my weight in the last 3 months.You drink more than two alcoholic drinks per day.My blood tests show high triglycerides, blood sugar, HbA1c, or insulin levels.Your weight in relation to your height falls within a certain range.I am taking medication that affects my blood sugar or cholesterol levels.You don't like the taste of fish or seafood.You are allergic to fish, seafood, milk protein, or any non-medicine ingredients.You are unable to digest lactose.You smoke cigarettes.I haven't used protein or probiotic supplements, or antibiotics in the last 3 months.I have not had major surgery in the last 3 months.Your waist measurement is 94 centimeters or more if you're a man, or 80 centimeters or more if you're a woman.
Research Study Groups:
This trial has the following groups:- Group 1: Comparator
- Group 2: SPF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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