SPF1Supplementation with Salmon Peptide Fraction in Overweight-Obese Men and Women: Safety, Cardiometabolic Health Effects and Mechanisms of Action
Supplement dose 15g/d
+ Supplement dose 7.5g/d
Hyperinsulinism+3
+ Insulin Resistance
+ Metabolic Diseases
Prevention Study
Summary
Study start date: November 1, 2021
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.53 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location