Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D

Not Applicable

Completed

• Conditions: Insulin Resistance; Prediabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Fish peptide supplement; Dietary Supplement: Fish peptide + Vitamin D3 supplements; Dietary Supplement: Vitamin D supplement

• Registration Number: NCT02668159
• Lead Sponsor: Laval University

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.

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Fish peptide	Fish peptide supplement	-
Fish peptide + Vitamin D	Fish peptide + Vitamin D3 supplements	-
Vitamin D	Vitamin D supplement	-

Primary Outcome Measures

Name	Time	Method
Serum glucose area under the curve (Glucose AUC)	0-180 min	The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Nutrition and Functional Foods (INAF), Laval University; 🇨🇦 Quebec, Canada