ObesityMUSCAADENCT02716740
Study of Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.
A study testing Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Despite the demonstrable health and quality of life benefits, there are unknowns within consequences of obesity surgery. Weight loss composition is poorly understood. The objective is to have a significant loss of body fat and a limited loss of muscular weight. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2017to 13 Jul 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years of age and younger than 65 years of age,
- Patient received an obesity-surgery (gastric bypass or sleeve gastrectomy)
- Contribution of muscular weight higher than 15% of the total weight loss after the third month post-surgery.
- Patient that be able to increase their physical activity
- Patient that give their informed consent before any procedure for the study
- Patient affiliated with a health insurance scheme
Who cannot join
- Patients allergic to one of the supplement's compound.
- Patients with glucocorticoid therapy
- Patients with hyperthyroidism
- Patients commencing insulin treatment or growth hormone
- Protein powder intake (as nutritional complement or as anabolic substance for muscle building practice)
- Oral nutritional supplement intake for malnutrition
Show all 15Show fewer
- Bone fracture since the surgery
- Infection can cause hypercatabolism (like microbial outbreak or chronic gastric fistula)
- Hospitalization for more than 24 hours since the surgery
- Known physical handicap
- Inability to increase physical activity during 3 months after beginning of the supplementation
- Enteral or parenteral nutrition
- Patients over 158 kg (DEXA impossible)
- Protected adults (guardianship by court order)
- Pregnant woman or breastfeeding.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Endocrinology, metabolic diseases and nutrition
Toulouse, 31059
About this study
Official title: Pilot Study of Branched Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.
Despite the demonstrable health and quality of life benefits, there are unknowns within consequences of obesity surgery. Weight loss composition is poorly understood. The objective is to have a significant loss of body fat and a limited loss of muscular weight.
A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and 1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little loss' and is defined by a contribution of muscular weight lower than 15% of the total weight loss. The other one is called 'big loss' and is defined by a contribution of muscular weight higher than 15% of the total weight loss. Causes of these different phenotypes are unknown for the moment.
Read more
Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in clinical situations like hepatic cirrhosis, and some populations like new born and older people.
Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit effect on the muscular mass. That is testing the influence of the quality of protein consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain of muscle only if it is associated to regular physical training, all patients will follow a physical training.
Read the detailed description
An excessive loss of lean mass could have negative metabolic consequences. Indeed, lean mass is an essential determinant of weight loss and of the glycaemia regulation. An important loss of muscular mass could expose the person to a reduction of quality of life (because of fatigue), or even a functional loss. Muscles are important for insulin sensibility and glucose metabolism. Muscles are proteolysis target and proteins will be used as sources of amino acid for other cellular functions.
Changes in lean mass have been at the centre of several studies, but changes in muscular mass after bariatric surgery have been report only one time.
A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and 1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little loss' and is defined by a contribution of muscular weight lower than 15% of the total weight loss. The other one is called 'big loss' and is defined by a contribution of muscular weight higher than 15% of the total weight loss. Causes of these different phenotypes are unknown for the moment. Nothing distinguishes them before the surgery. Type of surgery, gender, protein intake (in grams of proteins intake per day) do not appear to have a determining influence about the intensity of muscle mass loss. The only other study published shows changes in muscular mass about 15% at 6 weeks.
Relation between glycaemia changes and muscle mass changes suggests that patients with modest changes in muscular mass are patients who have the best improvement of glycaemia after surgery. It is the reason why, it could be interesting to preserve muscular mass.
Nowadays, there is no consensual strategy to compensate this loss of muscle mass. It is important to have in the same time an anabolic stimulus (training, hormone…) and a sufficient energy and protein intake.
According to a recent study which compares leucine intake with placebo during weight loss driven by a low-calorie diet associated to a muscle strengthening exercises, patients loss the same weight, but leucin group is gaining lean mass, while placebo group is losing it. Accordingly, twe different doses of amino acid will be tested of those used as diet supplement.
This study is testing the influence of the quality of protein consumed, more than the quantity. Patients will take leucine-enriched amino acid supplement and follow physical training. Aromatic amino acid supplementation showed an anabolic effect in older people, undernourished children and undernourished patients with chronic obstructive pulmonary disease. There are no known side effects. This amino acid supplementation has not been evaluated in post-obesity surgery context.
- Conditions
- Obesity
- Being tested
- Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week
- Keywords
- Post-obesity surgery, Leucine-enriched amino acid supplementation, Anabolic substance, Physical training, Muscular mass, Loss of weight
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per weekDietary supplement
After 3 months of obesity-surgery, if patients lost more than 15% of muscular weight, they will take a leucine-enriched amino acid supplementation during 3 months added with a regular physical training (30 minutes, 3 times/week). Arm A will take 2.46g/day of leucine-enriched amino acid supplementation and arm B 4g/day.
| Study group | Role | What they receive |
|---|---|---|
| Leucine-enriched amino acid : 2.16g/day | Experimental | Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (2.16g/day) Receives: Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week |
| Leucine-enriched amino acid : 4g/day | Experimental | Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (4g/day). Receives: Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in appendicular muscular mass at 3 months
Appendicular muscular mass measured by dual-energy X-ray absorptiometry (DEXA). It will be measured before and 3 months after supplementation.
Measured: Baseline and 3 months
Secondary outcomes (11)
Change from baseline in limbs muscular force at 3 months
The lower and higher limbs muscular force will be measured with a strain gauge.
Measured: Baseline and 3 months
Change from baseline in muscular function at 3 months
400 meters walking speed
Measured: Baseline and 3 months
Change from baseline in muscular function at 3 months
Chair-stand test
Measured: Baseline and 3 months
Change from baseline in muscular function at 3 months
Balance test by the Short Physical Performance Battery test
Measured: Baseline and 3 months
Change from baseline in fatigue at 3 months
Fatigue will be evaluate by the Pichot scale
Measured: Baseline and 3 months
Change from baseline in general functional assessment at 3 months
General function will be assessed by the Functional Status Questionnaire test.
Measured: Baseline and 3 months
Change from baseline in protein daily intake at 3 months
Patient will evaluate his/her protein daily intake (in g/day) by the Protein Intake Monitor with a digital tablet
Measured: Baseline and 3 months
Change from baseline in physical training adhesion at 3 months
Patients will have an exercise diary to write their organised physical activity. Physical activity will be converted in a multiple of basal metabolic rate.
Measured: Baseline and 3 months
Change from baseline in glucose metabolism at 3 months
Oral glucose tolerance test will be performed and glucose concentration will be determined into the blood.
Measured: Baseline and 3 months
Change from baseline in insulin secretion at 3 months
Oral glucose tolerance test will be performed and insulin concentration will be determined into the blood.
Measured: Baseline and 3 months
Change from baseline in leucine compliance
Leucine concentration and variation between visit before and after 3 months of supplementation will be measured by chromatography to assess the patient's compliance
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start8 Feb 2017
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Why it stopped: not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RITZ Patrick, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716740
- Sponsor's protocol ID
- RC31/15/7649
- Other IDs
- 2015-A01226-43
- Acronym
- MUSCAADE
- Status last verified
- Apr 2019
- First submitted
- 9 Mar 2016
- Last updated
- 3 Apr 2019
- 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 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Branched Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.
- ClinicalTrials.gov ID
- NCT02716740
- Acronym / sponsor ID
- MUSCAADE / RC31/15/7649
- Conditions
- Obesity
- Keywords
- Post-obesity surgery, Leucine-enriched amino acid supplementation, Anabolic substance, Physical training, Muscular mass, Loss of weight
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patient
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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.
Despite the demonstrable health and quality of life benefits, there are unknowns within consequences of obesity surgery. Weight loss composition is poorly understood. The objective is to have a significant loss of body fat and a limited loss of muscular weight.
A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and 1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little loss' and is defined by a contribution of muscular weight lower than 15% of the total weight loss. The other one is called 'big loss' and is defined by a contribution of muscular weight higher than 15% of the total weight loss. Causes of these different phenotypes are unknown for the moment.
Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in clinical situations like hepatic cirrhosis, and some populations like new born and older people.
Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit effect on the muscular mass. That is testing the influence of the quality of protein consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain of muscle only if it is associated to regular physical training, all patients will follow a physical training.
Detailed description
An excessive loss of lean mass could have negative metabolic consequences. Indeed, lean mass is an essential determinant of weight loss and of the glycaemia regulation. An important loss of muscular mass could expose the person to a reduction of quality of life (because of fatigue), or even a functional loss. Muscles are important for insulin sensibility and glucose metabolism. Muscles are proteolysis target and proteins will be used as sources of amino acid for other cellular functions.
Changes in lean mass have been at the centre of several studies, but changes in muscular mass after bariatric surgery have been report only one time.
A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and 1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little loss' and is defined by a contribution of muscular weight lower than 15% of the total weight loss. The other one is called 'big loss' and is defined by a contribution of muscular weight higher than 15% of the total weight loss. Causes of these different phenotypes are unknown for the moment. Nothing distinguishes them before the surgery. Type of surgery, gender, protein intake (in grams of proteins intake per day) do not appear to have a determining influence about the intensity of muscle mass loss. The only other study published shows changes in muscular mass about 15% at 6 weeks.
Relation between glycaemia changes and muscle mass changes suggests that patients with modest changes in muscular mass are patients who have the best improvement of glycaemia after surgery. It is the reason why, it could be interesting to preserve muscular mass.
Nowadays, there is no consensual strategy to compensate this loss of muscle mass. It is important to have in the same time an anabolic stimulus (training, hormone…) and a sufficient energy and protein intake.
According to a recent study which compares leucine intake with placebo during weight loss driven by a low-calorie diet associated to a muscle strengthening exercises, patients loss the same weight, but leucin group is gaining lean mass, while placebo group is losing it. Accordingly, twe different doses of amino acid will be tested of those used as diet supplement.
This study is testing the influence of the quality of protein consumed, more than the quantity. Patients will take leucine-enriched amino acid supplement and follow physical training. Aromatic amino acid supplementation showed an anabolic effect in older people, undernourished children and undernourished patients with chronic obstructive pulmonary disease. There are no known side effects. This amino acid supplementation has not been evaluated in post-obesity surgery context.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucine-enriched amino acid : 2.16g/day | Experimental | Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per weekDietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (2.16g/day) |
| Leucine-enriched amino acid : 4g/day | Experimental | Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per weekDietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (4g/day). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient older than 18 years of age and younger than 65 years of age,
- Patient received an obesity-surgery (gastric bypass or sleeve gastrectomy)
- Contribution of muscular weight higher than 15% of the total weight loss after the third month post-surgery.
- Patient that be able to increase their physical activity
- Patient that give their informed consent before any procedure for the study
Key exclusion criteria (15 listed)
- Patients allergic to one of the supplement's compound.
- Patients with glucocorticoid therapy
- Patients with hyperthyroidism
- Patients commencing insulin treatment or growth hormone
- Protein powder intake (as nutritional complement or as anabolic substance for muscle building practice)
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 |
|---|---|---|
| Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per weekAfter 3 months of obesity-surgery, if patients lost more than 15% of muscular weight, they will take a leucine-enriched amino acid supplementation during 3 months added with a regular physical training (30 minutes, 3 times/week). Arm A will take 2.46g/day of leucine-enriched amino acid supplementation and arm B 4g/day. | Dietary supplement | Leucine-enriched amino acid : 2.16g/day, Leucine-enriched amino acid : 4g/day |
Primary outcome
Change from baseline in appendicular muscular mass at 3 months
Time frame: Baseline and 3 months
Appendicular muscular mass measured by dual-energy X-ray absorptiometry (DEXA). It will be measured before and 3 months after supplementation.
11 secondary outcomes
Change from baseline in limbs muscular force at 3 months
Time frame: Baseline and 3 months
Change from baseline in muscular function at 3 months
Time frame: Baseline and 3 months
Change from baseline in muscular function at 3 months
Time frame: Baseline and 3 months
Change from baseline in muscular function at 3 months
Time frame: Baseline and 3 months
Change from baseline in fatigue at 3 months
Time frame: Baseline and 3 months
Change from baseline in general functional assessment at 3 months
Time frame: Baseline and 3 months
Change from baseline in protein daily intake at 3 months
Time frame: Baseline and 3 months
Change from baseline in physical training adhesion at 3 months
Time frame: Baseline and 3 months
Change from baseline in glucose metabolism at 3 months
Time frame: Baseline and 3 months
Change from baseline in insulin secretion at 3 months
Time frame: Baseline and 3 months
Change from baseline in leucine compliance
Time frame: Baseline and 3 months
Results and safety
The study was stopped early (reason given: not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- 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.
RITZ Patrick, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 Apr 2019. 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 France. 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 was stopped early (reason given: not enough patient). Results are not available in the source record.
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?
Change from baseline in appendicular muscular mass at 3 months (time frame: Baseline and 3 months). 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 3 Apr 2019.