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

February 13, 2024 updated by: Violeta Moizé, Hospital Clinic of Barcelona

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Violeta L Moizé, PhD
  • Phone Number: 2326 34932275400
  • Email: vmoize@clinic.cat

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 months after BS
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
8 months after BS
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
12 months after BS
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
4 months after BS
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
8 months after BS
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
12 months after BS
Strength
Time Frame: 4 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
4 months after BS
Strength
Time Frame: 8 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
8 months after BS
Strength
Time Frame: 12 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
12 months after BS
Functionality
Time Frame: 4 months after BS
changes from baseline on sit and stand
4 months after BS
Functionality
Time Frame: 8 months after BS
changes from baseline on sit and stand
8 months after BS
Functionality
Time Frame: 12 months after BS
changes from baseline on sit and stand
12 months after BS
Metabolic flexibility - oxidation of substrates: VO2 peak
Time Frame: 4 months after BS
change in VO2 peak measured by Ergocard during half-effort test
4 months after BS
Metabolic flexibility - oxidation of substrates: VO2 peak
Time Frame: 8 months after BS
change in VO2 peak measured by Ergocard
8 months after BS
Metabolic flexibility - oxidation of substrates: VO2 peak
Time Frame: 12 months after BS
change in VO2 peak measured by Ergocard during half-effort test
12 months after BS
Respiratory quotient
Time Frame: 4 months after BS
change in RQ determined by Ergocard during half-effort test
4 months after BS
Respiratory quotient
Time Frame: 8 months after BS
change in RQ determined by Ergocard during half-effort test
8 months after BS
Respiratory quotient
Time Frame: 12 months after BS
change in RQ determined by Ergocard during half-effort test
12 months after BS
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)
4 months after BS
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)
8 months after BS
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)
12 months after BS
Adherence to PS (BCAA biomarker)
Time Frame: 4 months after BS
serum change in BCAA (mcg)
4 months after BS
Adherence to PS (BCAA biomarker)
Time Frame: 8 months after BS
serum change in BCAA (mcg)
8 months after BS
Adherence to PS (BCAA biomarker)
Time Frame: 12 months after BS
serum change in BCAA (mcg)
12 months after BS
Adherence to PS (urinary nitrogen 24hs.)
Time Frame: 4 months after BS
Nitrogen (mg) values quantified in 24hs urine
4 months after BS
Adherence to PS (urinary nitrogen 24hs.)
Time Frame: 8 months after BS
Nitrogen (mg) values quantified in 24hs urine
8 months after BS
Adherence to PS (urinary nitrogen 24hs.)
Time Frame: 12 months after BS
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
Time Frame: 12 months after BS
identify by focus group patient reported outcomes by cualitative study
12 months after BS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in BMI
Time Frame: 4 months after BS
weight and height will be combined to report BMI in kg/m^2
4 months after BS
Changes in BMI
Time Frame: 8 months after BS
weight and height will be combined to report BMI in kg/m^2
8 months after BS
Changes in BMI
Time Frame: 12 months after BS
weight and height will be combined to report BMI in kg/m^2
12 months after BS
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
4 months after BS
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
8 months after BS
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
12 months after BS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Clinic of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Nacional d'Educacio Fisica de Catalunya
Garmin International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Violeta L Moizé, PhD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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