Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309563
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Metabolic Effects of a Diet Replaced With Essential Amino Acids
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Study on the Metabolic Effects of a Diet Replaced With Essential Amino Acids and Carboxylic Acids EAA-AC in Patients With Severe Obesity
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMINOB
Brief Summary:
The effectiveness of low-protein diets supplemented with essential aminoacid EAA formulas in genetic disorders of amino acid AA catabolism such as maple syrup urine disease MSUD is widely recognized Blackburn PR et al 2017 The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids essential tricarboxylic acids - EAA-AC For this reason patients of both sexes aged between 45 and 65 suffering from high-grade obesity will be recruited in Piancavallo The enrolled patients divided randomly into two groups will be given EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day the control group will follow a low-calorie and low-protein diet only with placebo The parameters considered after two weeks of treatment will be weight loss the maintenancerecovery of muscle mass assessed through changes in body composition and functional tests Hand grip 6MWT or TUG but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA the improvement of the glucose picture and the lipid profile
1 month after discharge patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing
1 month after discharge patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None