Effects of a Marine Protein Hydrolysate in Healthy Adults
Condition: Healthy Diet
Study type: Interventional

Summary: 
      This randomized, double blind, controlled trial investigates changes in the cardiovascular
      index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein
      hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons.
      Additionally, the study investigates potential effects on plasma parameters of metabolic
      health including lipids, glucose, inflammatory parameters and redox state, as well as
      associations between dietary MPH and body weight, abdominal obesity, body composition, and
      gut microbiota composition. Finally, putative end-products of diet-microbial interactions
      (TMAO and short-chain fatty acids) with CVD risk factors and biomarkers of mitochondrial
      function are examined.
    

Detailed description: 
      Marine protein sources, including fish and fish protein hydrolysates, may have particular
      health benefits. Health benefits from fish consumption have been attributed to the n-3
      polyunsaturated fatty acids, in particular eicosapentaenoic acid (EPA) and docosahexaenoic
      acid (DHA). Proteins from marine sources may contain valuable bioactive components, with
      amino acid composition and protein profiles that differ from terrestrial sources. Generally,
      the dietary source of protein can affect cellular energy metabolism, and hydrolyzed peptides
      can have potent and specific bioactive potential.

      Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis
      production (Food Grade). Freshly minced RRM were treated with enzymes optimized to generate
      bioactive hydrolysates using facilities and techniques approved for human consumption. The
      investigational products are given in a dose of 18 g protein per day, corresponding to the
      protein content of a standard meal, and similar to doses recommended in a range of protein
      supplements.

      The study enrolls around 70 men and women age of 20-80 years with waist circumference of <
      102 cm for men and < 88 cm for women. Prospective study participants were informed of the
      study and invited to participate through advertising primarily in social media (Facebook
      advertisement, geographically limited to 12 km surrounding the city centers of Bergen and
      Ålesund). Participants provided written informed consent, and were screened via
      self-reporting in an online form in EasyTrial hosted by the Research Unit for Clinical Trials
      at the University of Bergen. Data collection by the study staff at baseline verifies
      inclusion and exclusion criteria and participant eligibility prior to randomization. The
      potential participants are informed about practical details at a digital or physical meeting
      1-2 weeks prior to baseline.

      Groups of participants (40-60% males/females) are block randomized to the two treatments
      using randomly selected block sizes, and stratified according to sex.

      The participants are given a container with the powder sufficient for the entire study
      period, and a spoon to measure the intake at breakfast (6 g), lunch (6 g) and supper (6 g),
      or morning (9 g) and evening (9 g) according to individual preference. The patients will mix
      the powder products in water or mineral water. Flavours have been masked by supplementation
      with beet powder, and mixing 0.5 g fish hydrolysate per serving in the placebo, to minimize
      differences in taste of the placebo and active product.
    

Intervention name(s): Cod protein hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM is treated wth enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption.; Whey protein powder, commercially available
Other intervention name(s): Whey protein powder
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, placebo controlled clinical study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiovascular disease risk; Protein supplementation; Metabolic health