Ignite Creation Date:
2025-12-18 @ 9:17 AM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT02716740
Status:
None
Last Update Posted:
2019-04-03 00:00:00
First Post:
2016-03-09 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.
Sponsor:
None
Organization:
Study Overview
Official Title:
Pilot Study of Branched Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.
Status:
None
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough patient
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSCAADE
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: