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Completed

NCT Number: NCT04771377

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein supplementation

Dietary Supplement

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

Other names: Physical training, standard protein supplementation

Primary outcomes

  1. effect of PS and PA on Changes in fat mass and Fat free mass (kg)

    Time frame: 4 months after BS

    change from baseline in DEXA values

  2. effect of PS and PA on Changes in fat mass and Fat free mass (kg)

    Time frame: 8 months after BS

    change from baseline in DEXA values

  3. effect of PS and PA on Changes in fat mass and Fat free mass (kg)

    Time frame: 12 months after BS

    change from baseline in DEXA values

  4. effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)

    Time frame: 4 months after BS

    change from baseline in estimated REE from indirect calorimety

  5. effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)

    Time frame: 8 months after BS

    change from baseline in estimated REE from indirect calorimety

  6. effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)

    Time frame: 12 months after BS

    change from baseline in estimated REE from indirect calorimety

  7. Strength

    Time frame: 4 months after BS

    changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.

  8. Strength

    Time frame: 8 months after BS

    changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.

  9. Strength

    Time frame: 12 months after BS

    changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.

  10. Functionality

    Time frame: 4 months after BS

    changes from baseline on sit and stand

  11. Functionality

    Time frame: 8 months after BS

    changes from baseline on sit and stand

  12. Functionality

    Time frame: 12 months after BS

    changes from baseline on sit and stand

  13. Metabolic flexibility - oxidation of substrates: VO2 peak

    Time frame: 4 months after BS

    change in VO2 peak measured by Ergocard during half-effort test

  14. Metabolic flexibility - oxidation of substrates: VO2 peak

    Time frame: 8 months after BS

    change in VO2 peak measured by Ergocard

  15. Metabolic flexibility - oxidation of substrates: VO2 peak

    Time frame: 12 months after BS

    change in VO2 peak measured by Ergocard during half-effort test

  16. Respiratory quotient

    Time frame: 4 months after BS

    change in RQ determined by Ergocard during half-effort test

  17. Respiratory quotient

    Time frame: 8 months after BS

    change in RQ determined by Ergocard during half-effort test

  18. Respiratory quotient

    Time frame: 12 months after BS

    change in RQ determined by Ergocard during half-effort test

  19. Fat oxidation (FatMax) during during half-effort test

    Time frame: 4 months after BS

    Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

  20. Fat oxidation (FatMax) during during half-effort test

    Time frame: 8 months after BS

    Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

  21. Fat oxidation (FatMax) during during half-effort test

    Time frame: 12 months after BS

    Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)

  22. Adherence to PS (BCAA biomarker)

    Time frame: 4 months after BS

    serum change in BCAA (mcg)

  23. Adherence to PS (BCAA biomarker)

    Time frame: 8 months after BS

    serum change in BCAA (mcg)

  24. Adherence to PS (BCAA biomarker)

    Time frame: 12 months after BS

    serum change in BCAA (mcg)

  25. Adherence to PS (urinary nitrogen 24hs.)

    Time frame: 4 months after BS

    Nitrogen (mg) values quantified in 24hs urine

  26. Adherence to PS (urinary nitrogen 24hs.)

    Time frame: 8 months after BS

    Nitrogen (mg) values quantified in 24hs urine

  27. Adherence to PS (urinary nitrogen 24hs.)

    Time frame: 12 months after BS

    Nitrogen (mg) values quantified in 24hs urine

  28. 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

    Time frame: 12 months after BS

    identify by focus group patient reported outcomes by cualitative study

Secondary outcomes

  1. Changes in BMI

    Time frame: 4 months after BS

    weight and height will be combined to report BMI in kg/m^2

  2. Changes in BMI

    Time frame: 8 months after BS

    weight and height will be combined to report BMI in kg/m^2

  3. Changes in BMI

    Time frame: 12 months after BS

    weight and height will be combined to report BMI in kg/m^2

  4. Insulin sensitivity (HOMA-IR)

    Time frame: 4 months after BS

    fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in

  5. Insulin sensitivity (HOMA-IR)

    Time frame: 8 months after BS

    fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in

  6. Insulin sensitivity (HOMA-IR)

    Time frame: 12 months after BS

    fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Garmin International
  • Institut Nacional d'Educacio Fisica de Catalunya

Registry information

Official study 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

Acronym: SarcoFit

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2021
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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