Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D

Insulin Resistance Clinical Trial

— BONITO  

Official title:

Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668159
• Other study ID #: BONITO 2015-090
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Insulin Resistance
• Prediabetes

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