Skip to main content
OpenTrials
Completed

NCT Number: NCT02668159

Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, G1V 0A6, Canada

About this study

Sedentary lifestyle and excess calorie intake have contributed to a dramatic increase in the occurrence of obesity, metabolic syndrome (MetS), type 2 diabetes (T2D) and cardiovascular disease (CVD) The first step in reducing the excessive CVD risk associated with the presence of the MetS is the adoption of a healthier lifestyle. A balanced diet, including high-nutritive and low-energy foods such as fish, is an important component of a healthy diet. Fish is a major source of n-3 PUFA, high-quality protein, and other essential nutrients such as vitamin D. Fish consumption may therefore improve the components of the MetS and reduce the incidence of T2D and CVD in obese subjects.The foundation of this project stems from the well-recognized fact that few Canadians meet the weekly dietary recommendation for fish consumption (i.e. 2 servings/week) and thus intakes of both n-3 polyunsaturated fatty acid (PUFA) and fish protein are low in the general population, and even lower in obese subjects. Since some people simply dislike fish and because certain types of fish contain toxic contaminants, including heavy metals and environmental pollutants, fish consumption remains low. Therefore, dietary choices limit intake of its key nutrients, thus increasing risk for MetS, T2D and CVD. Also, fish is one of the richest food sources of dietary vitamin D which may also contribute to the health benefits of fish consumption. Indeed, it is currently estimated that ∼40% of Canadians have low serum 25-hydroxyvitamin D [25(OH)D] concentrations (≤50 nM) and that ∼70% are below 75 nM. In addition, obesity is an important risk factor for low serum 25(OH)D.The main objective of this study is to investigate the acute effects and mechanisms of action of fish peptide and vitamin D on glucose metabolism, parameters of insulin sensibility and secretion, and cardiometabolic risk profile in overweight men.

A four-arm randomized crossover design will be used to test the metabolic effects of consuming prior to a 3h-oral glucose tolerance test (OGTT), supplements containing either fish peptide (3 grams), vitamin D3 (1000 IU), a combination of fish peptide + vitamin D3 or a placebo.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fish peptide supplement

Dietary Supplement

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

vitamin D supplement

Dietary Supplement

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

Fish peptide + Vitamin D3 supplements

Dietary Supplement

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

Placebo

Dietary Supplement

7 tablets of placebos administered prior to one the OGTT

Primary outcomes

  1. Serum glucose area under the curve (Glucose AUC)

    Time frame: 0-180 min

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

Secondary outcomes

  1. Serum insulin area under the curve (Insulin AUC)

    Time frame: 0-180 min

    Area under the curve for serum insulin

  2. Serum C-peptide area under the curve (C-peptide AUC)

    Time frame: 0-180 min

    Area under the curve for serum C-peptide

  3. Serum triglycerides concentrations

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

    changes in the triglycerides concentration at each time point of the OGTT

  4. Serum 25(OH)D concentrations

    Time frame: 4 weeks

    Changes in the 25(OH)D concentration measured before each OGTT

  5. Cardiometabolic risk profile in serum

    Time frame: 4 weeks

    Changes in cardiometabolic profile measured in serum before each OGTT

  6. Gene expression profile

    Time frame: 4 weeks

    peripheral blood mononuclear cells (PBMCs) gene expression

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients

Acronym: BONITO

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 29, 2016
Registry last updated
Jul 7, 2021

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.

Published trials that share one or more normalized conditions with this study.