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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02668159
Other study ID # BONITO 2015-090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date December 2017

Study information

Verified date July 2021
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fish peptide supplement
6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT
Vitamin D supplement
1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
Fish peptide + Vitamin D3 supplements
6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
Placebo
7 tablets of placebos administered prior to one the OGTT

Locations

Country Name City State
Canada Institute of Nutrition and Functional Foods (INAF), Laval University Quebec

Sponsors (2)

Lead Sponsor Collaborator
Laval University Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Serum insulin area under the curve (Insulin AUC) Area under the curve for serum insulin 0-180 min
Secondary Serum C-peptide area under the curve (C-peptide AUC) Area under the curve for serum C-peptide 0-180 min
Secondary Serum triglycerides concentrations changes in the triglycerides concentration at each time point of the OGTT -15, 0, 15, 30, 60, 120, 180 min post 75g glucose
Secondary Serum 25(OH)D concentrations Changes in the 25(OH)D concentration measured before each OGTT 4 weeks
Secondary Cardiometabolic risk profile in serum Changes in cardiometabolic profile measured in serum before each OGTT 4 weeks
Secondary Gene expression profile peripheral blood mononuclear cells (PBMCs) gene expression 4 weeks
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