NCT05025462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

August 24, 2021

Last Update Submit

March 13, 2025

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    Change between the beginning and the end of the intervention (6 weeks)

Secondary Outcomes (6)

  • Change in lipid profile

    Change between the beginning and the end of the intervention (6 weeks)

  • Change in glucose metabolism

    Change between the beginning and th end of the intervention (6 weeks)

  • Change in insulin secretion

    Change between the beginning and th end of the intervention (6 weeks)

  • Change in blood pressure

    Change between the beginning and th end of the intervention (6 weeks)

  • Change in body mass index

    Change between the beginning and th end of the intervention (6 weeks)

  • +1 more secondary outcomes

Study Arms (2)

SPF

EXPERIMENTAL

Salmon peptide fraction supplement: powder mixed in water

Dietary Supplement: Supplement dose 15g/dDietary Supplement: Supplement dose 7.5g/d

Comparator

ACTIVE COMPARATOR

Casein peptide fraction supplement: powder mixed in water

Dietary Supplement: Supplement dose 15g/dDietary Supplement: Supplement dose 7.5g/d

Interventions

Supplement dose 15g/dDIETARY_SUPPLEMENT

Supplementation with 15g/day of SPF or Comparator

ComparatorSPF
Supplement dose 7.5g/dDIETARY_SUPPLEMENT

Supplementation with 7.5g/d of SPF ou comparator

ComparatorSPF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INAF, Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 27, 2021

Study Start

November 1, 2021

Primary Completion

July 26, 2023

Study Completion

July 26, 2023

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

CA(1)