Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Protein Supplementation and a Structured Physical Exercise Program on Changes in Body Composition, Metabolic Flexibility (Energy Consumption of Substrates), and Functionality in Women During Weight Loss Induced by Bariatric Surgery.

Conditions
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Sarcopenic Obesity, Bariatric Surgery Candidate, Nutritional Deficiency, Protein Intolerance

Intervention / Treatment
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* Dietary Supplement: Protein Supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women ≥45 years of age who meet CB criteria: Body mass index (BMI) ≥40.0 kg / m2 or between 35.0 and 39.9 kg / m2 with comorbidities (metabolic diseases, cardiorespiratory diseases), sedentary lack of regular physical activity: <30 minutes / day and <3 days / week). Exclusion Criteria: presence of severe joint disease, severe liver disease, history of cardiovascular event or known heart disease, renal failure (defined as a FG <30 ml / min), type 1 or type 2 diabetes with HbA1c> 10%, being treated with drugs that may affect body composition (such as corticosteroids), exercise muscle strength-endurance regularly (more than 2 times / week), have previously undergone obesity surgery.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:2:1.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard protein supplementation (SPS)<br>0.8g protein/ IBW/ day | Dietary Supplement: Protein Supplementation<br>* protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT<br>* Other names: standard protein supplementation;|
| Experimental: High protein supplementation (HPS)<br>1.2g protein/ IBW/ day | Dietary Supplement: Protein Supplementation<br>* protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT<br>* Other names: standard protein supplementation;|
| Experimental: HPS + PA<br>1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks | Dietary Supplement: Protein Supplementation<br>* protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT<br>* Other names: standard protein supplementation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of PS and PA on Changes in fat mass and Fat free mass (kg) | change from baseline in DEXA values | 4 months after BS | 
| effect of PS and PA on Changes in fat mass and Fat free mass (kg) | change from baseline in DEXA values | 8 months after BS | 
| effect of PS and PA on Changes in fat mass and Fat free mass (kg) | change from baseline in DEXA values | 12 months after BS | 
| effect of PS and PA on resting energy expenditure (REE) (Kcal/ day) | change from baseline in estimated REE from indirect calorimety | 4 months after BS | 
| effect of PS and PA on resting energy expenditure (REE) (Kcal/ day) | change from baseline in estimated REE from indirect calorimety | 8 months after BS | 
| effect of PS and PA on resting energy expenditure (REE) (Kcal/ day) | change from baseline in estimated REE from indirect calorimety | 12 months after BS | 
| Strength | changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip. | 4 months after BS | 
| Strength | changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip. | 8 months after BS | 
| Strength | changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip. | 12 months after BS | 
| Functionality | changes from baseline on sit and stand | 4 months after BS | 
| Functionality | changes from baseline on sit and stand | 8 months after BS | 
| Functionality | changes from baseline on sit and stand | 12 months after BS | 
| Metabolic flexibility - oxidation of substrates: VO2 peak | change in VO2 peak measured by Ergocard during half-effort test | 4 months after BS | 
| Metabolic flexibility - oxidation of substrates: VO2 peak | change in VO2 peak measured by Ergocard | 8 months after BS | 
| Metabolic flexibility - oxidation of substrates: VO2 peak | change in VO2 peak measured by Ergocard during half-effort test | 12 months after BS | 
| Respiratory quotient | change in RQ determined by Ergocard during half-effort test | 4 months after BS | 
| Respiratory quotient | change in RQ determined by Ergocard during half-effort test | 8 months after BS | 
| Respiratory quotient | change in RQ determined by Ergocard during half-effort test | 12 months after BS | 
| Fat oxidation (FatMax) during during half-effort test | Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min) | 4 months after BS | 
| Fat oxidation (FatMax) during during half-effort test | Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min) | 8 months after BS | 
| Fat oxidation (FatMax) during during half-effort test | Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min) | 12 months after BS | 
| Adherence to PS (BCAA biomarker) | serum change in BCAA (mcg) | 4 months after BS | 
| Adherence to PS (BCAA biomarker) | serum change in BCAA (mcg) | 8 months after BS | 
| Adherence to PS (BCAA biomarker) | serum change in BCAA (mcg) | 12 months after BS | 
| Adherence to PS (urinary nitrogen 24hs.) | Nitrogen (mg) values quantified in 24hs urine | 4 months after BS | 
| Adherence to PS (urinary nitrogen 24hs.) | Nitrogen (mg) values quantified in 24hs urine | 8 months after BS | 
| Adherence to PS (urinary nitrogen 24hs.) | Nitrogen (mg) values quantified in 24hs urine | 12 months after BS | 
| Understand patients' priorities and the painful points of the care process. Explore the magnitude of these painful points. This should make it possible to prioritize the areas to be evaluated. Test assessment tools | identify by focus group patient reported outcomes by cualitative study | 12 months after BS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMI | weight and height will be combined to report BMI in kg/m^2 | 4 months after BS | 
| Changes in BMI | weight and height will be combined to report BMI in kg/m^2 | 8 months after BS | 
| Changes in BMI | weight and height will be combined to report BMI in kg/m^2 | 12 months after BS | 
| Insulin sensitivity (HOMA-IR) | fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in | 4 months after BS | 
| Insulin sensitivity (HOMA-IR) | fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in | 8 months after BS | 
| Insulin sensitivity (HOMA-IR) | fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in | 12 months after BS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Physical training, Postmenopausal Women