Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery.
Condition: Sarcopenic Obesity; Bariatric Surgery Candidate; Nutritional Deficiency; Protein Intolerance
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Obesity is considered a chronic disease that increases the risk of developing diseases that
      reduce life expectancy. The treatment of obesity is complex. However, treatments based
      exclusively on dietary changes have not shown long-term efficacy especially in people with
      severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good
      long-term results in weight loss and maintenance. These changes are accompanied by
      significant improvements in health, improved quality of life, and reduced mortality. However,
      the changes in the digestive system created by BS and the high level of dietary restriction,
      affect the nutritional status and require a proper supplementation of vitamins and minerals
      during the follow-up. Intense weight loss during the first few months, coupled with an
      insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive
      muscle loss during the short-term period can lead to functional repercussions (decreased
      strength and physical function) and reduced calories that the body burns daily. Naturally,
      this is especially important in people suffering from sarcopenia before BS, and it occurs
      more frequently in postmenopausal women. Despite this is known, specific protein intake
      recommendations after BS have not yet been defined based on scientific evidence. In this
      context, the first part of our proposal will assess the effect of two levels of protein
      supplementation: standard (S-PS) versus high (H-PS) on changes in a) body composition, b)
      energy expenditure, c) metabolic flexibility d) the physical condition during weight loss
      that follows BS. In addition, in patients with H-PS, the added effect of a physical exercise
      program, carried out with a personal trainer (professional of sports medicine trainer)
      virtually, will be evaluated. Protein supplementation and the virtual exercise program will
      be done during the 4 months following BS, and the results will be studied at 4, 8, and 12
      months. Once the results have been defined, it is essential to transfer the recommendations
      to the real world. In a second part, and to achieve knowledge transfer to clinical practice,
      the investigators will explore the key elements that influence patient experience (XPA).
    

Detailed description: 
      Obesity is considered a chronic disease that increases the risk of developing diseases that
      reduce life expectancy. The treatment of obesity is complex. However, treatments based
      exclusively on dietary changes have not shown long-term efficacy especially in people with
      severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good
      long-term results in weight loss and maintenance. These changes are accompanied by
      significant improvements in health, improved quality of life, and reduced mortality. However,
      the changes in the digestive system created by BS and the high level of dietary restriction,
      affect the nutritional status and require a proper supplementation of vitamins and minerals
      during the follow-up. Intense weight loss during the first few months, coupled with an
      insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive
      muscle loss during the short-term period can lead to functional repercussions (decreased
      strength and physical function) and reduced calories that the body burns daily. Naturally,
      this is especially important in people suffering from sarcopenia before BS, and it occurs
      more frequently in postmenopausal women. Despite this is known, specific protein intake
      recommendations after BS have not yet been defined based on scientific evidence. In this
      context, the first part of our proposal will assess the effect of two levels of protein
      supplementation: standard (SP-S) versus high (SP-A) on changes in a) body composition, b)
      energy expenditure, c) metabolic flexibility d) the physical condition during weight loss
      that follows BS. In addition, in patients with SP-Alta, the added effect of a physical
      exercise program, carried out with a personal trainer (professional of sports medicine
      trainer) virtually, will be evaluated. Protein supplementation and the virtual exercise
      program will be done during the 4 months following CO, and the results will be studied at 4,
      8, and 12 months. Once the results have been defined, it is essential to transfer the
      recommendations to the real world. In a second part, and to achieve knowledge transfer to
      clinical practice, the investigators will explore the key elements that influence patient
      experience (XPA). The investigators will define indicators to assess it, especially those
      that are related to adherence to nutritional recommendations and to changes in lifestyle. The
      investigators are currently in the recruitment phase of the study. I have studied the
      necessary elements, ambitions and included the components that will help to define the
      dietary and lifestyle recommendations for our population. Aim to facilitate and define the
      performance of the professionals providing realistic, based on the XPA and in this way to
      improve the impact of the CO on health and quality of life. This is an ambitious and
      necessary study and includes all the component that will help define dietary and lifestyle
      recommendations for our population. It aims to facilitate and define the action of
      professionals provides realistic tools, based on XPA and thus improve the impact of BS on
      health and quality of life.

      Description of the population to study sedentary women, candidates for BS at our institution.
    

Intervention name(s): Protein Supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT
Other intervention name(s): Physical training; standard protein supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:2:1.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sarcopenia; Physical training; Postmenopausal Women