Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      In this randomized, placebo controlled, double blind trial, effects of relatively high doses
      of chicken protein hydrolysate (CPH) or casein hydrolysate (placebo) supplementation will be
      investigate in healthy persons with abdominal obesity. The 12-week study examines potential
      effects on body weight, abdominal obesity, body composition, plasma parameters of metabolic
      health including lipids, inflammatory parameters, redox state and microbiota biomarkers.
    

Detailed description: 
      Small peptides in the range of 2 - 12 amino acids are believed to cross the intestinal wall
      undigested and enter the circulation where they can have a range of activities based on their
      amino acid composition and structure. Natural peptides isolated from a number of food
      proteins, including plants and marine organisms, are shown to have antioxidant effects in in
      vitro tests, and anti-hypertensive effects in mice through inhibition of the
      angiotensin-converting-enzyme (ACE). Protein hydrolysates from both animal- and plant-based
      sources will consist of a mixture of potentially bioactive peptides that can have specific
      effects based on their composition. Studies have shown that egg- and soy-derived hydrolysates
      have anti-diabetic and anti-obesity properties in rodents. Pre-clinical studies in mice have
      demonstrated potent plasma cytokine lowering abilities and atherosclerosis-prevention by
      chicken protein hydrolysate (CPH) diets, as well as effects on plasma cholesterol level,
      cytokines and lipid metabolism, including mitochondrial function. In addition, an isolated
      peptide fraction from chicken inhibits the dipeptyl peptidase IV, and thus has the potential
      to restore glucose homeostasis in type 2 diabetics.

      The hydrolysate supplements used in this study are obtained from rest raw materials (RRM)
      from mechanical deboning of chicken meat (Food Grade, Nortura AS Hærland, Norway). Freshly
      minced chicken RRM has been treated with enzymes optimized to generate bioactive
      hydrolysates. The supplement is 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 protein shake
      supplements.

      Around 60 males and females age >20 years with abdominal obesity participate, recruited
      primarily through social media advertisements (Facebook) limited to a 12 km radius around the
      city center of Bergen. 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 (CPH
      or placebo casein supplementation) using randomly selected block sizes, and stratified
      according to sex.

      The participants are given a container with the powder sufficient for the entire 12-week
      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.
    

Intervention name(s): Chicken protein hydrolysate supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions; Daily oral self-administration of 18 g of supplement dissolved in water/mineral water, spread over 2-3 occasions
Other intervention name(s): CPH; Casein
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiovascular disease risk; Protein supplementation; Metabolic health