- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05025462
Salmon Peptide Fraction: Safety and Cardiometabolic Health (SPF1)
Supplementation With Salmon Peptide Fraction in Overweight-Obese Men and Women: Safety, Cardiometabolic Health Effects and Mechanisms of Action
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Geneviève Pilon, PhD
- Phone Number: 3783 418-656-8711
- Email: Genevieve.Pilon@criucpq.ulaval.ca
Study Contact Backup
- Name: Julie Marois, MSc
- Phone Number: 405764 418-656-2131
- Email: julie.marois@fsaa.ulaval.ca
Study Locations
-
-
-
Québec, Canada, G1V 0A6
- INAF, Université Laval
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPF
Salmon peptide fraction supplement: powder mixed in water
|
Supplementation with 15g/day of SPF or Comparator
Supplementation with 7.5g/d of SPF ou comparator
|
Active Comparator: Comparator
Casein peptide fraction supplement: powder mixed in water
|
Supplementation with 15g/day of SPF or Comparator
Supplementation with 7.5g/d of SPF ou comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 between the beginning and the end of the intervention (6 weeks)
|
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 between the beginning and the end of the intervention (6 weeks)
|
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
|
Change between the beginning and the end of the intervention (6 weeks)
|
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
|
Change between the beginning and the end of the intervention (6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lipid profile
Time Frame: Change between the beginning and the end of the intervention (6 weeks)
|
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids
|
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)
|
Evaluation of blood glucose concentration during a 3h oral glucose tolerance test
|
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)
|
Evaluation of blood insulin and C-peptide concentration during a 3h oral glucose tolerance test
|
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)
|
Evaluation of systolic and diastolic blood pressure to test metabolic syndrome risk factors
|
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)
|
Evaluation of BMI by measuring weight and height to test metabolic risk factors
|
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)
|
Measure of waist circumference to test metabolic risk factors
|
Change between the beginning and th end of the intervention (6 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPF1 2021-157
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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