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Trial record 23 of 1007 for:    Area Under Curve AND insulin

Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D (BONITO)

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ClinicalTrials.gov Identifier: NCT02668159
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marie-Claude Vohl, 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.

Condition or disease Intervention/treatment Phase
Prediabetes Insulin Resistance Dietary Supplement: Fish peptide supplement Dietary Supplement: Vitamin D supplement Dietary Supplement: Fish peptide + Vitamin D3 supplements Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Fish peptide Dietary Supplement: Fish peptide supplement
6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT

Experimental: Vitamin D Dietary Supplement: Vitamin D supplement
1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT

Experimental: Fish peptide + Vitamin D Dietary Supplement: 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 Comparator: Control Dietary Supplement: Placebo
7 tablets of placebos administered prior to one the OGTT




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668159


Locations
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Canada
Institute of Nutrition and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Marie-Claude Vohl Instute of Nutrition and Functional Foods, Laval University

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Responsible Party: Marie-Claude Vohl, Professor, Laval University
ClinicalTrials.gov Identifier: NCT02668159     History of Changes
Other Study ID Numbers: BONITO 2015-090
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Insulin Resistance
Prediabetic State
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents