Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D
Condition: Prediabetes; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

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.
    

Intervention name(s): Fish peptide supplement; Vitamin D supplement; Fish peptide + Vitamin D3 supplements; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT; 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT; 6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT; 7 tablets of placebos administered prior to one the OGTT
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention