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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04771377
Acronym
SarcoFit
Enrollment
75
Registered
2021-02-25
Start date
2020-11-10
Completion date
2023-06-30
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sarcopenia, Physical training, Postmenopausal Women

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.

Interventions

DIETARY_SUPPLEMENTProtein Supplementation

protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT

Sponsors

Garmin International
CollaboratorINDUSTRY
Institut Nacional d'Educacio Fisica de Catalunya
CollaboratorOTHER
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

2:2:1.

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 tools12 months after BSidentify by focus group patient reported outcomes by cualitative study
Adherence to PS (BCAA biomarker)4 months after BSserum change in BCAA (mcg)
Adherence to PS (urinary nitrogen 24hs.)4 months after BSNitrogen (mg) values quantified in 24hs urine
effect of PS and PA on Changes in fat mass and Fat free mass (kg)4 months after BSchange from baseline in DEXA values
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)4 months after BSchange from baseline in estimated REE from indirect calorimety
Strength4 months after BSchanges from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Functionality4 months after BSchanges from baseline on sit and stand
Metabolic flexibility - oxidation of substrates: VO2 peak4 months after BSchange in VO2 peak measured by Ergocard during half-effort test
Respiratory quotient4 months after BSchange in RQ determined by Ergocard during half-effort test
Fat oxidation (FatMax) during during half-effort test4 months after BSTime to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

Secondary

MeasureTime frameDescription
Insulin sensitivity (HOMA-IR)4 months after BSfasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Changes in BMI4 months after BSweight and height will be combined to report BMI in kg/m\^2

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026