Metabolic SyndromeSPF1NCT05025462
Salmon Peptide Fraction: Safety and Cardiometabolic Health
A study testing Supplement dose 15g/d and Supplement dose 7.5g/d in people with Metabolic Syndrome, run by Laval University at 1 site in Canada.
Trial summary
The overall goal of this study is to verify the safety of 15g of salmon peptide fraction (SPF), and to test the effects on metabolic syndrome risk factors of two doses of SPF (7.5g and 15g) in overweight-obese men and women. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Supplement dose 15g/d and Supplement dose 7.5g/d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 26 Jul 2023
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25 and 35 kg/m2
- Waist circumference ≥ 94 cm for men and ≥ 80 cm for women
- 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
Who cannot join
- Smoker
- Suffering from any metabolic disorder requiring pharmacological treatment
- Taking any medications or natural health products affecting glucose metabolism or plasma lipid levels
- Use of protein supplements, probiotics supplements or antibiotics within the last 3 months
- Taste aversion for fish/seafood
- Fish-seafood or casein/milk protein or any non-medicinal ingredients allergy
Show all 11Show fewer
- Lactose intolerance
- Regular alcohol consumption (>2 drinks/d)
- >5% weight loss over the last 3 months
- Major surgery within the last 3 months
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementation with Salmon Peptide Fraction in Overweight-Obese Men and Women: Safety, Cardiometabolic Health Effects and Mechanisms of Action
The overall goal of this study is to verify the safety of 15g of salmon peptide fraction (SPF), and to test the effects on metabolic syndrome risk factors of two doses of SPF (7.5g and 15g) in overweight-obese men and women. Transcriptomic, metabolomic and metagenomic approaches will be used to study the physiological effects of SPF and to discover the potential mechanism underlying these effects.
Read the detailed description
Increased fish consumption has been suggested to improve the metabolic syndrome (MetS) and to reduce the incidence of type 2 diabetes (T2D) and cardiovascular disease (CVD) in obese subjects. While it is well documented that marine long chain polyunsaturated fatty acids (n-3 PUFA) decrease CVD risk by improving the plasma lipid profile and reducing inflammation, the beneficial effects of n-3 PUFA on glucose homeostasis and insulin sensitivity in humans remains highly controversial. Animal and human studies carried out by the group of investigators over the past 20 years have shown that fish proteins can improve the plasma lipid profile, enhance insulin sensitivity and reduce obesity-linked inflammation. The investigators also reported that a salmon protein hydrolysate reduces body fat and increases insulin sensitivity via its calcitonin content and they observed that protein hydrolysates from salmon and other fish sources reduced inflammation in visceral adipose tissue in rodents. The investigators therefore decided a few years ago to focus on the identification of bioactive peptides from fish proteins to explore the potential of increasing the efficacy of fish muscle protein hydrolysates to prevent/treat the MetS. The investigators hypothesized that it was the peptides produced from gastrointestinal digestion that were responsible for the remarkable bioactive effects of fish proteins on the MetS. The investigators have also confirmed that a small peptides fraction (SPF) from salmon protein markedly reduces the development of T2D and inflammation in a high-fat diet (HFD)-induced, obese, atherosclerosis-prone mouse LDLr knockout (KO). These findings are very promising and suggest that fish protein-derived peptides or amino acids may also explain the beneficial effects of dietary fish intake on the MetS, T2D and CVD. Additional studies are required to validate these observations, delineate the mechanisms, and assess their direct impact in human clinical trials.
Subjects will take an oral dose of 15 g of SPF or comparator per day (powder mixed with water) in the first intervention phase (6 weeks), then 7.5 g of SPF or comparator per day (powder mixed with water) in the second intervention phase (6 weeks).
- Conditions
- Metabolic Syndrome
- Being tested
- Supplement dose 15g/d, Supplement dose 7.5g/d
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement dose 15g/dDietary supplement
Supplementation with 15g/day of SPF or Comparator
Supplement dose 7.5g/dDietary supplement
Supplementation with 7.5g/d of SPF ou comparator
| Study group | Role | What they receive |
|---|---|---|
| SPF | Experimental | Salmon peptide fraction supplement: powder mixed in water Receives: Dietary Supplement: Supplement dose 15g/d; Dietary Supplement: Supplement dose 7.5g/d |
| Comparator | Active comparator | Casein peptide fraction supplement: powder mixed in water Receives: Dietary Supplement: Supplement dose 15g/d; Dietary Supplement: Supplement dose 7.5g/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic enzymes using blood sampling
Measure hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) to test the safety of SPF
Measured: Change between the beginning and the end of the intervention (6 weeks)
Change in renal function using blood sampling
Measure creatinine to test the safety of SPF
Measured: Change between the beginning and the end of the intervention (6 weeks)
Change in complete blood count using blood sampling
Measure of complete blood count to test th safety of SPF
Measured: Change between the beginning and the end of the intervention (6 weeks)
Adverse event and general acceptability evaluated by questionnaires
To test the safety of SPF
Measured: Change between the beginning and the end of the intervention (6 weeks)
Secondary outcomes (6)
Change in lipid profile
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids
Measured: Change between the beginning and the end of the intervention (6 weeks)
Change in glucose metabolism
Evaluation of blood glucose concentration during a 3h oral glucose tolerance test
Measured: Change between the beginning and th end of the intervention (6 weeks)
Change in insulin secretion
Evaluation of blood insulin and C-peptide concentration during a 3h oral glucose tolerance test
Measured: Change between the beginning and th end of the intervention (6 weeks)
Change in blood pressure
Evaluation of systolic and diastolic blood pressure to test metabolic syndrome risk factors
Measured: Change between the beginning and th end of the intervention (6 weeks)
Change in body mass index
Evaluation of BMI by measuring weight and height to test metabolic risk factors
Measured: Change between the beginning and th end of the intervention (6 weeks)
Change in waist circumference
Measure of waist circumference to test metabolic risk factors
Measured: Change between the beginning and th end of the intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Nov 2021
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Marette, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025462
- Sponsor's protocol ID
- SPF1 2021-157
- Acronym
- SPF1
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation with Salmon Peptide Fraction in Overweight-Obese Men and Women: Safety, Cardiometabolic Health Effects and Mechanisms of Action
- ClinicalTrials.gov ID
- NCT05025462
- Acronym / sponsor ID
- SPF1 / SPF1 2021-157
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 27 Aug 2021 (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 overall goal of this study is to verify the safety of 15g of salmon peptide fraction (SPF), and to test the effects on metabolic syndrome risk factors of two doses of SPF (7.5g and 15g) in overweight-obese men and women. Transcriptomic, metabolomic and metagenomic approaches will be used to study the physiological effects of SPF and to discover the potential mechanism underlying these effects.
Detailed description
Increased fish consumption has been suggested to improve the metabolic syndrome (MetS) and to reduce the incidence of type 2 diabetes (T2D) and cardiovascular disease (CVD) in obese subjects. While it is well documented that marine long chain polyunsaturated fatty acids (n-3 PUFA) decrease CVD risk by improving the plasma lipid profile and reducing inflammation, the beneficial effects of n-3 PUFA on glucose homeostasis and insulin sensitivity in humans remains highly controversial. Animal and human studies carried out by the group of investigators over the past 20 years have shown that fish proteins can improve the plasma lipid profile, enhance insulin sensitivity and reduce obesity-linked inflammation. The investigators also reported that a salmon protein hydrolysate reduces body fat and increases insulin sensitivity via its calcitonin content and they observed that protein hydrolysates from salmon and other fish sources reduced inflammation in visceral adipose tissue in rodents. The investigators therefore decided a few years ago to focus on the identification of bioactive peptides from fish proteins to explore the potential of increasing the efficacy of fish muscle protein hydrolysates to prevent/treat the MetS. The investigators hypothesized that it was the peptides produced from gastrointestinal digestion that were responsible for the remarkable bioactive effects of fish proteins on the MetS. The investigators have also confirmed that a small peptides fraction (SPF) from salmon protein markedly reduces the development of T2D and inflammation in a high-fat diet (HFD)-induced, obese, atherosclerosis-prone mouse LDLr knockout (KO). These findings are very promising and suggest that fish protein-derived peptides or amino acids may also explain the beneficial effects of dietary fish intake on the MetS, T2D and CVD. Additional studies are required to validate these observations, delineate the mechanisms, and assess their direct impact in human clinical trials.
Subjects will take an oral dose of 15 g of SPF or comparator per day (powder mixed with water) in the first intervention phase (6 weeks), then 7.5 g of SPF or comparator per day (powder mixed with water) in the second intervention phase (6 weeks).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPF | Experimental | Dietary Supplement: Supplement dose 15g/d, Dietary Supplement: Supplement dose 7.5g/dSalmon peptide fraction supplement: powder mixed in water |
| Comparator | Active comparator | Dietary Supplement: Supplement dose 15g/d, Dietary Supplement: Supplement dose 7.5g/dCasein peptide fraction supplement: powder mixed in water |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 25 and 35 kg/m2
- Waist circumference ≥ 94 cm for men and ≥ 80 cm for women
- 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
Key exclusion criteria (11 listed)
- Smoker
- Suffering from any metabolic disorder requiring pharmacological treatment
- Taking any medications or natural health products affecting glucose metabolism or plasma lipid levels
- Use of protein supplements, probiotics supplements or antibiotics within the last 3 months
- Taste aversion for fish/seafood
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 |
|---|---|---|
| Supplement dose 15g/dSupplementation with 15g/day of SPF or Comparator | Dietary supplement | Comparator, SPF |
| Supplement dose 7.5g/dSupplementation with 7.5g/d of SPF ou comparator | Dietary supplement | Comparator, SPF |
Primary outcome
Change in hepatic enzymes using blood sampling
Time frame: Change between the beginning and the end of the intervention (6 weeks)
Measure hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) to test the safety of SPF
Change in renal function using blood sampling
Time frame: Change between the beginning and the end of the intervention (6 weeks)
Measure creatinine to test the safety of SPF
Change in complete blood count using blood sampling
Time frame: Change between the beginning and the end of the intervention (6 weeks)
Measure of complete blood count to test th safety of SPF
Adverse event and general acceptability evaluated by questionnaires
Time frame: Change between the beginning and the end of the intervention (6 weeks)
To test the safety of SPF
6 secondary outcomes
Change in lipid profile
Time frame: Change between the beginning and the end of the intervention (6 weeks)
Change in glucose metabolism
Time frame: Change between the beginning and th end of the intervention (6 weeks)
Change in insulin secretion
Time frame: Change between the beginning and th end of the intervention (6 weeks)
Change in blood pressure
Time frame: Change between the beginning and th end of the intervention (6 weeks)
Change in body mass index
Time frame: Change between the beginning and th end of the intervention (6 weeks)
Change in waist circumference
Time frame: Change between the beginning and th end of the intervention (6 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 18 Mar 2025.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement dose 15g/d and Supplement dose 7.5g/d in people with Metabolic Syndrome, run by Laval University at 1 site in Canada.
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 4 inclusion and 11 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in hepatic enzymes using blood sampling (time frame: Change between the beginning and the end of the intervention (6 weeks)). The study lists 4 primary outcomes in all. 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 18 Mar 2025.