High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00983983 |
Recruitment Status :
Completed
First Posted : September 24, 2009
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
|
Sponsor:
Massachusetts General Hospital
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 23, 2009 | |||
First Posted Date ICMJE | September 24, 2009 | |||
Results First Submitted Date ICMJE | September 16, 2014 | |||
Results First Posted Date ICMJE | February 27, 2015 | |||
Last Update Posted Date | February 27, 2015 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
Adverse events and subject compliance rates. [ Time Frame: 5 months follow-up ] | |||
Change History | Complete list of historical versions of study NCT00983983 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
Biomarkers of Body Composition and Lipid Metabolism [ Time Frame: 5 months follow-up ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis | |||
Official Title ICMJE | Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis | |||
Brief Summary | The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (ALS) (Lou Gehrig's disease). | |||
Detailed Description | Weight loss is a common and severe symptom of amyotrophic lateral sclerosis (ALS), caused both from inadequate calorie intake and an increased metabolic rate. People with ALS are generally instructed to increase their calorie intake; however, the ideal amount and type of calories has not been studied. Several studies in an animal model of motor neuron disease have shown that a high fat/high calorie diet can increase survival by as much as 38%. Mice on a high fat diet also live longer than mice fed diets consisting of high protein or high sugar. We are therefore conducting a phase II safety, tolerability, and preliminary efficacy trial in ALS of high fat versus high calorie versus normal diet. The normal diet will be calculated based on the number of calories needed to replace each participant's measured daily calorie requirement. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
|||
Condition ICMJE | Amyotrophic Lateral Sclerosis | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
28 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | May 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00983983 | |||
Other Study ID Numbers ICMJE | MDA136152 2009-P-001132 |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE | Muscular Dystrophy Association | |||
Investigators ICMJE |
|
|||
PRS Account | Massachusetts General Hospital | |||
Verification Date | February 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |