Clinical trial NCT04771377: Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery.
Official title: 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 BS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenic Obesity
Bariatric Surgery Candidate
Nutritional Deficiency
Protein Intolerance
Keywords: Sarcopenia
Physical training
Postmenopausal Women
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Garmin International
name: Institut Nacional d'Educacio Fisica de Catalunya
First posted: 2021-02-25
Enrollment: 75
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:2:1.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: effect of PS and PA on Changes in fat mass and Fat free mass (kg)
timeFrame: 4 months after BS
measure: effect of PS and PA on Changes in fat mass and Fat free mass (kg)
timeFrame: 8 months after BS
measure: effect of PS and PA on Changes in fat mass and Fat free mass (kg)
timeFrame: 12 months after BS
measure: effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
timeFrame: 4 months after BS
measure: effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
timeFrame: 8 months after BS
measure: effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
timeFrame: 12 months after BS
measure: Strength
timeFrame: 4 months after BS
measure: Strength
timeFrame: 8 months after BS
measure: Strength
timeFrame: 12 months after BS
measure: Functionality
timeFrame: 4 months after BS
measure: Functionality
timeFrame: 8 months after BS
measure: Functionality
timeFrame: 12 months after BS
measure: Metabolic flexibility - oxidation of substrates: VO2 peak
timeFrame: 4 months after BS
measure: Metabolic flexibility - oxidation of substrates: VO2 peak
timeFrame: 8 months after BS
measure: Metabolic flexibility - oxidation of substrates: VO2 peak
timeFrame: 12 months after BS
measure: Respiratory quotient
timeFrame: 4 months after BS
measure: Respiratory quotient
timeFrame: 8 months after BS
measure: Respiratory quotient
timeFrame: 12 months after BS
measure: Fat oxidation (FatMax) during during half-effort test
timeFrame: 4 months after BS
measure: Fat oxidation (FatMax) during during half-effort test
timeFrame: 8 months after BS
measure: Fat oxidation (FatMax) during during half-effort test
timeFrame: 12 months after BS
measure: Adherence to PS (BCAA biomarker)
timeFrame: 4 months after BS
measure: Adherence to PS (BCAA biomarker)
timeFrame: 8 months after BS
measure: Adherence to PS (BCAA biomarker)
timeFrame: 12 months after BS
measure: Adherence to PS (urinary nitrogen 24hs.)
timeFrame: 4 months after BS
measure: Adherence to PS (urinary nitrogen 24hs.)
timeFrame: 8 months after BS
measure: Adherence to PS (urinary nitrogen 24hs.)
timeFrame: 12 months after BS
measure: 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
timeFrame: 12 months after BS
Secondary outcomes:
measure: Changes in BMI
timeFrame: 4 months after BS
measure: Changes in BMI
timeFrame: 8 months after BS
measure: Changes in BMI
timeFrame: 12 months after BS
measure: Insulin sensitivity (HOMA-IR)
timeFrame: 4 months after BS
measure: Insulin sensitivity (HOMA-IR)
timeFrame: 8 months after BS
measure: Insulin sensitivity (HOMA-IR)
timeFrame: 12 months after BS
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Violeta L Moizé, PhD
role: PRINCIPAL_INVESTIGATOR
References: