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

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

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).

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Sarcopenic Obesity; Nutritional Deficiency; Protein Intolerance
• Intervention / Treatment: Dietary supplement: Protein Supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard protein supplementation (SPS); 0.8g protein/ IBW/ day	Dietary supplement: Protein Supplementation; 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
Experimental: High protein supplementation (HPS); 1.2g protein/ IBW/ day	Dietary supplement: Protein Supplementation; 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
Experimental: HPS + PA; 1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks	Dietary supplement: Protein Supplementation; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Institut Nacional d'Educacio Fisica de Catalunya; Garmin International
• Investigators: Principal Investigator: Violeta L Moizé, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Sarcopenia; Postmenopausal Women; Physical training
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: HCB/2020/0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No