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NCT Number: NCT05025462

Salmon Peptide Fraction: Safety and Cardiometabolic Health

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INAF, Université Laval

Québec, Quebec, G1V 0A6, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplement dose 15g/d

Dietary Supplement

Supplementation with 15g/day of SPF or Comparator

Supplement dose 7.5g/d

Dietary Supplement

Supplementation with 7.5g/d of SPF ou comparator

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Supplementation with Salmon Peptide Fraction in Overweight-Obese Men and Women: Safety, Cardiometabolic Health Effects and Mechanisms of Action

Acronym: SPF1

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2021
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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