Pilot Study of Branched Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change from baseline in appendicular muscular mass at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
Leucine-enriched amino acid : 2.16g/day
Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (2.16g/day)
干预措施: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (Dietary Supplement)
Leucine-enriched amino acid : 4g/day
Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (4g/day).
干预措施: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week (Dietary Supplement)
结局指标
主要结局
Change from baseline in appendicular muscular mass at 3 months
时间窗: 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.
次要结局
- Change from baseline in limbs muscular force at 3 months(Baseline and 3 months)
- Change from baseline in glucose metabolism at 3 months(Baseline and 3 months)
- Change from baseline in protein daily intake at 3 months(Baseline and 3 months)
- Change from baseline in insulin secretion at 3 months(Baseline and 3 months)
- Change from baseline in fatigue at 3 months(Baseline and 3 months)
- Change from baseline in physical training adhesion at 3 months(Baseline and 3 months)
- Change from baseline in general functional assessment at 3 months(Baseline and 3 months)
- Change from baseline in leucine compliance(Baseline and 3 months)
- Change from baseline in muscular function at 3 months(Baseline and 3 months)