Clinical trial NCT05025462: Salmon Peptide Fraction: Safety and Cardiometabolic Health
Official title: Supplementation with Salmon Peptide Fraction in Overweight-Obese Men and Women: Safety, Cardiometabolic Health Effects and Mechanisms of Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility 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

Primary outcomes:
measure: Change in hepatic enzymes using blood sampling
timeFrame: Change between the beginning and the end of the intervention (6 weeks)
measure: Change in renal function using blood sampling
timeFrame: Change between the beginning and the end of the intervention (6 weeks)
measure: Change in complete blood count using blood sampling
timeFrame: Change between the beginning and the end of the intervention (6 weeks)
measure: Adverse event and general acceptability evaluated by questionnaires
timeFrame: Change between the beginning and the end of the intervention (6 weeks)
Secondary outcomes:
measure: Change in lipid profile
timeFrame: Change between the beginning and the end of the intervention (6 weeks)
measure: Change in glucose metabolism
timeFrame: Change between the beginning and th end of the intervention (6 weeks)
measure: Change in insulin secretion
timeFrame: Change between the beginning and th end of the intervention (6 weeks)
measure: Change in blood pressure
timeFrame: Change between the beginning and th end of the intervention (6 weeks)
measure: Change in body mass index
timeFrame: Change between the beginning and th end of the intervention (6 weeks)
measure: Change in waist circumference
timeFrame: Change between the beginning and th end of the intervention (6 weeks)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: INAF, Université Laval
state: Quebec
Study officials:
References: