Sarcopenic ObesitySarcoFitNCT04771377
Effect of Protein Supplementation and a Structured Exercise Program on Muscle in Women After Bariatric Surgery.
A study testing Protein Supplementation in people with Sarcopenic Obesity and Bariatric Surgery Candidate, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Sarcopenic Obesity, Bariatric Surgery Candidate, Nutritional Deficiency
- What is being tested?
- Protein Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 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).
Read the 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.
- Conditions
- Sarcopenic Obesity, Bariatric Surgery Candidate, Nutritional Deficiency, Protein Intolerance
- Being tested
- Protein Supplementation
- Keywords
- Sarcopenia, Physical training, Postmenopausal Women
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein SupplementationDietary supplement
Also called Physical training, standard protein supplementation
protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT
| Study group | Role | What they receive |
|---|---|---|
| standard protein supplementation (SPS) | Experimental | 0.8g protein/ IBW/ day Receives: Dietary Supplement: Protein Supplementation |
| High protein supplementation (HPS) | Experimental | 1.2g protein/ IBW/ day Receives: Dietary Supplement: Protein Supplementation |
| HPS + PA | Experimental | 1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks Receives: Dietary Supplement: Protein Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of PS and PA on Changes in fat mass and Fat free mass (kg)
change from baseline in DEXA values
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after BS
Strength
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Measured: 4 months after BS
Strength
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Measured: 8 months after BS
Strength
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Measured: 12 months after BS
Functionality
changes from baseline on sit and stand
Measured: 4 months after BS
Functionality
changes from baseline on sit and stand
Measured: 8 months after BS
Functionality
changes from baseline on sit and stand
Measured: 12 months after BS
Metabolic flexibility - oxidation of substrates: VO2 peak
change in VO2 peak measured by Ergocard during half-effort test
Measured: 4 months after BS
Metabolic flexibility - oxidation of substrates: VO2 peak
change in VO2 peak measured by Ergocard
Measured: 8 months after BS
Metabolic flexibility - oxidation of substrates: VO2 peak
change in VO2 peak measured by Ergocard during half-effort test
Measured: 12 months after BS
Respiratory quotient
change in RQ determined by Ergocard during half-effort test
Measured: 4 months after BS
Respiratory quotient
change in RQ determined by Ergocard during half-effort test
Measured: 8 months after BS
Respiratory quotient
change in RQ determined by Ergocard during half-effort test
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months after BS
Adherence to PS (BCAA biomarker)
serum change in BCAA (mcg)
Measured: 4 months after BS
Adherence to PS (BCAA biomarker)
serum change in BCAA (mcg)
Measured: 8 months after BS
Adherence to PS (BCAA biomarker)
serum change in BCAA (mcg)
Measured: 12 months after BS
Adherence to PS (urinary nitrogen 24hs.)
Nitrogen (mg) values quantified in 24hs urine
Measured: 4 months after BS
Adherence to PS (urinary nitrogen 24hs.)
Nitrogen (mg) values quantified in 24hs urine
Measured: 8 months after BS
Adherence to PS (urinary nitrogen 24hs.)
Nitrogen (mg) values quantified in 24hs urine
Measured: 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
Measured: 12 months after BS
Secondary outcomes (6)
Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 4 months after BS
Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 8 months after BS
Changes in BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 12 months after BS
Insulin sensitivity (HOMA-IR)
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Measured: 4 months after BS
Insulin sensitivity (HOMA-IR)
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Measured: 8 months after BS
Insulin sensitivity (HOMA-IR)
fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in
Measured: 12 months after BS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Nov 2020
- Primary completion10 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:2:1.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Garmin International, Institut Nacional d'Educacio Fisica de Catalunya
- Responsible party
- Principal investigator, Violeta Moizé, Hospital Clinic of Barcelona
- Investigators
- Violeta L Moizé, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771377
- Sponsor's protocol ID
- HCB/2020/0028
- Acronym
- SarcoFit
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 BS
- ClinicalTrials.gov ID
- NCT04771377
- Acronym / sponsor ID
- SarcoFit / HCB/2020/0028
- Conditions
- Sarcopenic Obesity, Bariatric Surgery Candidate, Nutritional Deficiency, Protein Intolerance
- Keywords
- Sarcopenia, Physical training, Postmenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Garmin International, Institut Nacional d'Educacio Fisica de Catalunya
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2:2:1.
| Arm | Type | Receives |
|---|---|---|
| standard protein supplementation (SPS) | Experimental | Dietary Supplement: Protein Supplementation0.8g protein/ IBW/ day |
| High protein supplementation (HPS) | Experimental | Dietary Supplement: Protein Supplementation1.2g protein/ IBW/ day |
| HPS + PA | Experimental | Dietary Supplement: Protein Supplementation1.2g protein/ IBW/ day + PA 3 times a week/ 12 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein SupplementationAlso: Physical training, standard protein supplementationprotein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT | Dietary supplement | HPS + PA, High protein supplementation (HPS), standard protein supplementation (SPS) |
Primary outcome
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
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
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
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
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
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
Strength
Time frame: 4 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Strength
Time frame: 8 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Strength
Time frame: 12 months after BS
changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip.
Functionality
Time frame: 4 months after BS
changes from baseline on sit and stand
Functionality
Time frame: 8 months after BS
changes from baseline on sit and stand
Functionality
Time frame: 12 months after BS
changes from baseline on sit and stand
Metabolic flexibility - oxidation of substrates: VO2 peak
Time frame: 4 months after BS
change in VO2 peak measured by Ergocard during half-effort test
Metabolic flexibility - oxidation of substrates: VO2 peak
Time frame: 8 months after BS
change in VO2 peak measured by Ergocard
Metabolic flexibility - oxidation of substrates: VO2 peak
Time frame: 12 months after BS
change in VO2 peak measured by Ergocard during half-effort test
Respiratory quotient
Time frame: 4 months after BS
change in RQ determined by Ergocard during half-effort test
Respiratory quotient
Time frame: 8 months after BS
change in RQ determined by Ergocard during half-effort test
Respiratory quotient
Time frame: 12 months after BS
change in RQ determined by Ergocard during half-effort test
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)
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)
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)
Adherence to PS (BCAA biomarker)
Time frame: 4 months after BS
serum change in BCAA (mcg)
Adherence to PS (BCAA biomarker)
Time frame: 8 months after BS
serum change in BCAA (mcg)
Adherence to PS (BCAA biomarker)
Time frame: 12 months after BS
serum change in BCAA (mcg)
Adherence to PS (urinary nitrogen 24hs.)
Time frame: 4 months after BS
Nitrogen (mg) values quantified in 24hs urine
Adherence to PS (urinary nitrogen 24hs.)
Time frame: 8 months after BS
Nitrogen (mg) values quantified in 24hs urine
Adherence to PS (urinary nitrogen 24hs.)
Time frame: 12 months after BS
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
Time frame: 12 months after BS
identify by focus group patient reported outcomes by cualitative study
6 secondary outcomes
Changes in BMI
Time frame: 4 months after BS
Changes in BMI
Time frame: 8 months after BS
Changes in BMI
Time frame: 12 months after BS
Insulin sensitivity (HOMA-IR)
Time frame: 4 months after BS
Insulin sensitivity (HOMA-IR)
Time frame: 8 months after BS
Insulin sensitivity (HOMA-IR)
Time frame: 12 months after BS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Violeta L Moizé, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Supplementation in people with Sarcopenic Obesity and Bariatric Surgery Candidate, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of PS and PA on Changes in fat mass and Fat free mass (kg) (time frame: 4 months after BS). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.