NCT02668159

Brief Summary

The overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to study the acute physiological effects of fish nutrients and to discover gene/metabolite networks that underlie these effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

September 1, 2015

Last Update Submit

July 5, 2021

Conditions

PrediabetesInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Serum glucose area under the curve (Glucose AUC)

    The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested

    0-180 min

Secondary Outcomes (6)

  • Serum insulin area under the curve (Insulin AUC)

    0-180 min

  • Serum C-peptide area under the curve (C-peptide AUC)

    0-180 min

  • Serum triglycerides concentrations

    -15, 0, 15, 30, 60, 120, 180 min post 75g glucose

  • Serum 25(OH)D concentrations

    4 weeks

  • Cardiometabolic risk profile in serum

    4 weeks

  • +1 more secondary outcomes

Study Arms (4)

Fish peptide

EXPERIMENTAL
Dietary Supplement: Fish peptide supplement

Vitamin D

EXPERIMENTAL
Dietary Supplement: Vitamin D supplement

Fish peptide + Vitamin D

EXPERIMENTAL
Dietary Supplement: Fish peptide + Vitamin D3 supplements

Control

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Fish peptide supplementDIETARY_SUPPLEMENT

6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT

Fish peptide
Vitamin D supplementDIETARY_SUPPLEMENT

1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT

Vitamin D
Fish peptide + Vitamin D3 supplementsDIETARY_SUPPLEMENT

6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT

Fish peptide + Vitamin D
PlaceboDIETARY_SUPPLEMENT

7 tablets of placebos administered prior to one the OGTT

Control

Eligibility Criteria

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

You may qualify if:

  • overweight (BMI 25-40 kg/m2)
  • fasting triglycerides ≥ 1.5 mmol/L
  • fasting insulin ≥ 60 pmol/L
  • non-smoking
  • stable weight in the past 3 months

You may not qualify if:

  • diabetes
  • chronic diseases
  • taking drugs that could affect glucose or lipid metabolism
  • taking dietary supplements or natural health products
  • major surgery 3 months prior to the study
  • fish or seafood allergy
  • lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Functional Foods (INAF), Laval University

Québec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Prediabetic StateInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Marie-Claude Vohl

    Instute of Nutrition and Functional Foods, Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2015

First Posted

January 29, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

CA(1)