Study of Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.

NCT02716740 | Terminated

• 2 other identifiers: RC31/15/76492015-A01226-43
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

Post-obesity surgery; Leucine-enriched amino acid supplementation; Anabolic substance; Physical training; Muscular mass; Loss of weight

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months

Secondary Outcomes (11)

• Change from baseline in limbs muscular force at 3 months

  Baseline and 3 months

• Change from baseline in muscular function at 3 months

  Baseline and 3 months

• Change from baseline in muscular function at 3 months

  Baseline and 3 months

• Change from baseline in muscular function at 3 months

  Baseline and 3 months

• Change from baseline in fatigue at 3 months

  Baseline and 3 months

Study Arms (2)

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)

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).

Dietary Supplement: Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week

Interventions

Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week DIETARY_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.

Leucine-enriched amino acid : 2.16g/day; Leucine-enriched amino acid : 4g/day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Department of Endocrinology, metabolic diseases and nutrition

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• RITZ Patrick, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 23, 2016
• Study Start: February 8, 2017
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)