Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280079
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-19
Brief Title:
Ultra-high-caloric Fatty Diet in ALS
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Efficacy Safety and Tolerability of Ultra-high-caloric Fatty Diet UFD in Amyotrophic Lateral Sclerosis ALS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
LIPCAL-ALS II
Brief Summary:
This study aims at evaluating efficacy and tolerability of an ultra-high-caloric fatty diet UFD compared to placebo in patients with amyotrophic lateral sclerosis ALS
Detailed Description:
ALS is a fatal neurodegenerative disease leading to progressive paralysis of voluntarily innervated muscles and to death caused by respiratory failure after a mean disease duration of 2-4 yearsThe proposed study aims at improving survival of ALS patients by targeting metabolic parameters ALS patients feature an intrinsic hypermetabolism as signified by an increased resting energy expenditure which significantly contributes to progressive weight loss and cachexia The extent of weight loss is an independent prognostic factor for survival in ALS It has been shown that survival of ALS mice can be prolonged by applying a high-caloric nutrition Furthermore ALS patients feature distinct alterations of lipid metabolism and various studies suggest a protective effect of high triglyceride serum levels
In the precursor-study LIPCAL-ALS-I a randomized placebo-controlled multicenter trial evaluating the effects of a high-caloric fatty diet HCFD the primary endpoint survival in the whole study population was missed However post-hoc analysis revealed showed that HCFD 1 increased survival and reduced weight loss in normal to fast-progressing patients patients with a functional decline measured by ALS Functional Rating Scale Revised above the median at baseline p002 2 slowed down functional decline measured by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised in the whole study population p00125 and 3 lowered neurofilament light chain NfL serum levels as a prognostic biomarker in the whole study population p00225
Therefore this study aims at prolonging survival in ALS patients by applying 15-fold dosage of the same intervention as in LIPCAL-ALS I in a larger number of patients excluding patients with slow disease progression
In the precursor-study LIPCAL-ALS-I a randomized placebo-controlled multicenter trial evaluating the effects of a high-caloric fatty diet HCFD the primary endpoint survival in the whole study population was missed However post-hoc analysis revealed showed that HCFD 1 increased survival and reduced weight loss in normal to fast-progressing patients patients with a functional decline measured by ALS Functional Rating Scale Revised above the median at baseline p002 2 slowed down functional decline measured by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised in the whole study population p00125 and 3 lowered neurofilament light chain NfL serum levels as a prognostic biomarker in the whole study population p00225
Therefore this study aims at prolonging survival in ALS patients by applying 15-fold dosage of the same intervention as in LIPCAL-ALS I in a larger number of patients excluding patients with slow disease progression
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?:
None
Is an FDA AA801 Violation?:
None