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

Primary Purpose

Sarcopenic Obesity, Bariatric Surgery Candidate, Nutritional Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Protein Supplementation
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenic Obesity focused on measuring Sarcopenia, Physical training, Postmenopausal Women

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clinic BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

standard protein supplementation (SPS)

High protein supplementation (HPS)

HPS + PA

Arm Description

0.8g protein/ IBW/ day

1.2g protein/ IBW/ day

1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks

Outcomes

Primary Outcome Measures

effect of PS and PA on Changes in fat mass and Fat free mass (kg)
change from baseline in DEXA values
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
change from baseline in DEXA values
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
change from baseline in DEXA values
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
change from baseline in estimated REE from indirect calorimety
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
change from baseline in estimated REE from indirect calorimety
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
change from baseline in estimated REE from indirect calorimety
Strength
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Strength
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Strength
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Functionality
changes from baseline on sit and stand
Functionality
changes from baseline on sit and stand
Functionality
changes from baseline on sit and stand
Metabolic flexibility - oxidation of substrates: VO2 peak
change in VO2 peak measured by Ergocard during half-effort test
Metabolic flexibility - oxidation of substrates: VO2 peak
change in VO2 peak measured by Ergocard
Metabolic flexibility - oxidation of substrates: VO2 peak
change in VO2 peak measured by Ergocard during half-effort test
Respiratory quotient
change in RQ determined by Ergocard during half-effort test
Respiratory quotient
change in RQ determined by Ergocard during half-effort test
Respiratory quotient
change in RQ determined by Ergocard during half-effort test
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)
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)
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)
Adherence to PS (BCAA biomarker)
serum change in BCAA (mcg)
Adherence to PS (BCAA biomarker)
serum change in BCAA (mcg)
Adherence to PS (BCAA biomarker)
serum change in BCAA (mcg)
Adherence to PS (urinary nitrogen 24hs.)
Nitrogen (mg) values quantified in 24hs urine
Adherence to PS (urinary nitrogen 24hs.)
Nitrogen (mg) values quantified in 24hs urine
Adherence to PS (urinary nitrogen 24hs.)
Nitrogen (mg) values quantified in 24hs urine
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

Secondary Outcome Measures

Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Insulin sensitivity (HOMA-IR)
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Insulin sensitivity (HOMA-IR)
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Insulin sensitivity (HOMA-IR)
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in

Full Information

First Posted
February 11, 2021
Last Updated
February 24, 2021
Sponsor
Hospital Clinic of Barcelona
Collaborators
Garmin International, Institut Nacional d'Educacio Fisica de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04771377
Brief Title
Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery.
Acronym
SarcoFit
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 Bariatric Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
February 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Garmin International, Institut Nacional d'Educacio Fisica de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenic Obesity, Bariatric Surgery Candidate, Nutritional Deficiency, Protein Intolerance
Keywords
Sarcopenia, Physical training, Postmenopausal Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:2:1.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard protein supplementation (SPS)
Arm Type
Experimental
Arm Description
0.8g protein/ IBW/ day
Arm Title
High protein supplementation (HPS)
Arm Type
Experimental
Arm Description
1.2g protein/ IBW/ day
Arm Title
HPS + PA
Arm Type
Experimental
Arm Description
1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein Supplementation
Other Intervention Name(s)
Physical training, standard protein supplementation
Intervention Description
protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT
Primary Outcome Measure Information:
Title
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
Description
change from baseline in DEXA values
Time Frame
4 months after BS
Title
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
Description
change from baseline in DEXA values
Time Frame
8 months after BS
Title
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
Description
change from baseline in DEXA values
Time Frame
12 months after BS
Title
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
Description
change from baseline in estimated REE from indirect calorimety
Time Frame
4 months after BS
Title
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
Description
change from baseline in estimated REE from indirect calorimety
Time Frame
8 months after BS
Title
effect of PS and PA on resting energy expenditure (REE) (Kcal/ day)
Description
change from baseline in estimated REE from indirect calorimety
Time Frame
12 months after BS
Title
Strength
Description
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Time Frame
4 months after BS
Title
Strength
Description
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Time Frame
8 months after BS
Title
Strength
Description
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Time Frame
12 months after BS
Title
Functionality
Description
changes from baseline on sit and stand
Time Frame
4 months after BS
Title
Functionality
Description
changes from baseline on sit and stand
Time Frame
8 months after BS
Title
Functionality
Description
changes from baseline on sit and stand
Time Frame
12 months after BS
Title
Metabolic flexibility - oxidation of substrates: VO2 peak
Description
change in VO2 peak measured by Ergocard during half-effort test
Time Frame
4 months after BS
Title
Metabolic flexibility - oxidation of substrates: VO2 peak
Description
change in VO2 peak measured by Ergocard
Time Frame
8 months after BS
Title
Metabolic flexibility - oxidation of substrates: VO2 peak
Description
change in VO2 peak measured by Ergocard during half-effort test
Time Frame
12 months after BS
Title
Respiratory quotient
Description
change in RQ determined by Ergocard during half-effort test
Time Frame
4 months after BS
Title
Respiratory quotient
Description
change in RQ determined by Ergocard during half-effort test
Time Frame
8 months after BS
Title
Respiratory quotient
Description
change in RQ determined by Ergocard during half-effort test
Time Frame
12 months after BS
Title
Fat oxidation (FatMax) during during half-effort test
Description
Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)
Time Frame
4 months after BS
Title
Fat oxidation (FatMax) during during half-effort test
Description
Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)
Time Frame
8 months after BS
Title
Fat oxidation (FatMax) during during half-effort test
Description
Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min)
Time Frame
12 months after BS
Title
Adherence to PS (BCAA biomarker)
Description
serum change in BCAA (mcg)
Time Frame
4 months after BS
Title
Adherence to PS (BCAA biomarker)
Description
serum change in BCAA (mcg)
Time Frame
8 months after BS
Title
Adherence to PS (BCAA biomarker)
Description
serum change in BCAA (mcg)
Time Frame
12 months after BS
Title
Adherence to PS (urinary nitrogen 24hs.)
Description
Nitrogen (mg) values quantified in 24hs urine
Time Frame
4 months after BS
Title
Adherence to PS (urinary nitrogen 24hs.)
Description
Nitrogen (mg) values quantified in 24hs urine
Time Frame
8 months after BS
Title
Adherence to PS (urinary nitrogen 24hs.)
Description
Nitrogen (mg) values quantified in 24hs urine
Time Frame
12 months after BS
Title
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
Description
identify by focus group patient reported outcomes by cualitative study
Time Frame
12 months after BS
Secondary Outcome Measure Information:
Title
Changes in BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
4 months after BS
Title
Changes in BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
8 months after BS
Title
Changes in BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
12 months after BS
Title
Insulin sensitivity (HOMA-IR)
Description
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Time Frame
4 months after BS
Title
Insulin sensitivity (HOMA-IR)
Description
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Time Frame
8 months after BS
Title
Insulin sensitivity (HOMA-IR)
Description
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Time Frame
12 months after BS

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study will only include women. The difference in muscle mass and strength justifies the need for this limitation. In addition, women account for 80% of CB cases in our Hospital and in the vast majority of literature series. Given that muscle mass loss and risk of sarcopenia are typical of older adults, our study (focused on the prevention and / or delay of the onset of sarcopenia) targets women over the age of 45 a first CB in our center. Although the results of this study will only be valid for this group, the resulting nutritional and lifestyle recommendations will be relevant as women are the majority in the use of CB. Addressing this goal in men would require a different protocol.
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Violeta L Moizé, PhD
Phone
34932275400
Ext
2326
Email
vmoize@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Violeta L Moizé, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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