Amyotrophic Lateral SclerosisPhase 3NCT01016522
Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)
A Phase 3 study testing KetoCal in people with Amyotrophic Lateral Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- KetoCal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
- Age 18 or older
- Capable of providing informed consent and complying with trial procedures
- Gastrostomy tube in place for the prior month
- Appel ALS score less than 100
- Able to stand on a scale with assistance
Show all 14Show fewer
- For patients with Appel ALS scores greater than 80, availability of caregiver who is willing and able to:
- Prepare, administer and log tube feeds
- Check and log gastric residuals
- Assist with weighing subject at home if necessary
- Willing to chart food intake during the six-month study
- Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days
- Not taking Coenzyme Q10 or on a stable dose and brand for 30 days
- Absence of exclusion criteria
Who cannot join
- Forced vital capacity <50% of predicted
- Dependence on mechanical ventilation for more than 12 hours per day
- Exposure to any experimental agent within 30 days of onset of this protocol
- Women who are pregnant or planning to become pregnant
- Women of childbearing potential not practicing contraception
- Enrollment in another research study within 30 days of or during this trial
Show all 15Show fewer
- Mini-Mental State Exam (MMSE) score <20
- Patients with symptomatic cardiac disease or hypercholesterolemia
- Patients with myocardial infarction within 6 months of this trial
- Renal dysfunction defined as BUN and creatinine >2XULN
- Known mitochondrial disease
- BMI<18.5
- Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial
- Impaired liver function, defined as AST or ALT of 3 X ULN
- Patients who have a pacemaker or other internal electronic medical device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerability of the Ketogenic Diet in ALS
This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- KetoCal
- Keywords
- ALS, Ketogenic Diet
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoCalDietary supplement
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| KetoCal | Experimental | KetoCal tube feeding formula Receives: Dietary Supplement: KetoCal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect
Measured: 28 weeks
Secondary outcomes (1)
Evaluate changes in motor function, strength, fatigue, body fat and cognitive function
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia North America, Cornell University
- Responsible party
- Principal investigator, Vinay Chaudhry, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016522
- Sponsor's protocol ID
- NA_00008855
- Status last verified
- Mar 2015
- First submitted
- 18 Nov 2009
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of the Ketogenic Diet in ALS
- ClinicalTrials.gov ID
- NCT01016522
- Acronym / sponsor ID
- NA_00008855
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS, Ketogenic Diet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Nutricia North America, Cornell University
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KetoCal | Experimental | Dietary Supplement: KetoCalKetoCal tube feeding formula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
- Age 18 or older
- Capable of providing informed consent and complying with trial procedures
- Gastrostomy tube in place for the prior month
- Appel ALS score less than 100
Key exclusion criteria (15 listed)
- Forced vital capacity <50% of predicted
- Dependence on mechanical ventilation for more than 12 hours per day
- Exposure to any experimental agent within 30 days of onset of this protocol
- Women who are pregnant or planning to become pregnant
- Women of childbearing potential not practicing contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetoCalKetogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates | Dietary supplement | KetoCal |
Primary outcome
Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect
Time frame: 28 weeks
1 secondary outcome
Evaluate changes in motor function, strength, fatigue, body fat and cognitive function
Time frame: 28 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KetoCal in people with Amyotrophic Lateral Sclerosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.