Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass
Condition: Obesity; Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      An intervention study design in 90 obese patients will be used. Nutritional, metabolic and
      psychological status as well as gut microbiota will be evaluated before gastric bypass and 6
      months post surgery. During this period of 6 months, all patients will receive a specific
      diet according to recommendation with regard to bariatric surgery.

      Subjects will be than randomized in 2 sub-groups:

      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.
      patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin
      and mineral supplementation
    

Detailed description: 
      The primary aim of the study is to analyse the micro-nutritional status in morbidly obese
      patients before and 6 months after bariatric surgery (Roux-en-Y gastric bypass, RYGB). The
      secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3
      acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12
      months post-RYGB.

      An intervention study in 90 obese patients (BMI>40 kg/m2) will be used. Nutritional,
      metabolic and psychological status as well as gut microbiota will be evaluated before gastric
      bypass and 6 months post RYGB. During this period of 6 months, all patients will receive a
      specific diet according to recommendation with regard to RYGB.

      Subjects will be than randomized in 2 sub-groups:

      A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B.
      patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin
      and mineral supplementation Healthy diet will be defined as follow: 9-15% of proteins, 50-55%
      of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25%
      poly-unsaturated fat).

      The following parameters will be analysed before RYGB and 6 months and 12 months post RYGB,
      respectively:

        -  Nutritional status with oxidative stress parameters (Vitamins A and E, Selenium, Zinc,
           Copper, Glutathione peroxidise, Superoxide dismutase and Iron)

        -  Metabolic parameters (Total cholesterol, LDL-cholesterol, HDL-cholesterol,
           Triglycerides, fasting glucose and insulin, CRP)

        -  Fatty acids (linoleic acid, alpha-linoleic acid (ALA), eicosapentaenoic acid (EPA), and
           docosahexaenoic acid (DHA)

        -  Gut microbiota

        -  Psychological status (anxiety, depression and quality of life as evaluated by validated
           questionnaires).
    

Intervention name(s): Diet supplementation; Bariatric surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Micronutriment supplementation therapy; Roux-en-Y gastric bypass provided in both arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment