Parkinson DiseaseNCT02687698
Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease
A study testing Ketogenic diet in people with Parkinson Disease, run by University of Padova at 1 site in Italy.
Trial summary
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a diagnosis of Parkinson's disease, treated with L-Dopa or other dopaminergic drugs.
- Mini Mental State Examination (MMSE) >24.
- Activities of Daily Living >3.
Who cannot join
- Mini nutritional assessment <17; BMI <18, hypoalbuminemia or lymphopenia.
- acute or chronic liver diseases;
- renal function impairment (Clearance creatinine <30ml/min);
- cancer;
- acute inflammatory diseases;
- thyroid diseases;
Show all 13Show fewer
- diabetes mellitus;
- dysphagia;
- dementia;
- dyslipidemia;
- history of recent cardiovascular or cerebrovascular events;
- psychiatric diseases;
- iatrogen parkinsonism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Lipidic and Proteic Controlled Diet on Resting Energy Expenditure, Body Composition and Symptoms in Patients With Parkinson's Disease
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in patients with Parkinson's disease.
Read the detailed description
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in Parkinson's disease patients.
- Conditions
- Parkinson Disease
- Being tested
- Ketogenic diet
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
The proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Patients will be suggested to follow a ketogenic diet for 8 weeks. Receives: Other: Ketogenic diet |
| Control | No intervention | Usual diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in resting energy expenditure
Changes in resting energy expenditure as measured by indirect calorimetry
Measured: Baseline, week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Trevisan, MD, Principal investigator, University of Padova, Geriatric Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687698
- Sponsor's protocol ID
- 3575/AO/15
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vanitallie TB, Nonas C, Di Rocco A, Boyar K, Hyams K, Heymsfield SB. Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. Neurology. 2005 Feb 22;64(4):728-30. doi: 10.1212/01.WNL.0000152046.11390.45.
PubMed 15728303Shehu E, Trevisan C, Sambo S, Ceolin C, Pavan S, Piazzani F, Sergi G, March A. Sex Differences in the Burden of Hip Fractures on Functional Status in Older Age. J Womens Health (Larchmt). 2023 Jan;32(1):57-62. doi: 10.1089/jwh.2021.0270. Epub 2022 Dec 1.
PubMed 36459629
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Lipidic and Proteic Controlled Diet on Resting Energy Expenditure, Body Composition and Symptoms in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02687698
- Acronym / sponsor ID
- 3575/AO/15
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 22 Feb 2016 (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.
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in patients with Parkinson's disease.
Detailed description
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in Parkinson's disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Other: Ketogenic dietPatients will be suggested to follow a ketogenic diet for 8 weeks. |
| Control | No intervention | –Usual diet. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a diagnosis of Parkinson's disease, treated with L-Dopa or other dopaminergic drugs.
- Mini Mental State Examination (MMSE) >24.
- Activities of Daily Living >3.
Key exclusion criteria (13 listed)
- Mini nutritional assessment <17; BMI <18, hypoalbuminemia or lymphopenia.
- acute or chronic liver diseases;
- renal function impairment (Clearance creatinine <30ml/min);
- cancer;
- acute inflammatory diseases;
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 |
|---|---|---|
| Ketogenic dietThe proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins. | Other | Ketogenic diet |
Primary outcome
Changes in resting energy expenditure
Time frame: Baseline, week 4 and week 8
Changes in resting energy expenditure as measured by indirect calorimetry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Results publication: PubMed 15728303Vanitallie TB, Nonas C, Di Rocco A, Boyar K, Hyams K, Heymsfield SB. Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. Neurology. 2005 Feb 22;64(4):728-30. doi: 10.1212/01.WNL.0000152046.11390.45.
- Derived from this study: PubMed 36459629Shehu E, Trevisan C, Sambo S, Ceolin C, Pavan S, Piazzani F, Sergi G, March A. Sex Differences in the Burden of Hip Fractures on Functional Status in Older Age. J Womens Health (Larchmt). 2023 Jan;32(1):57-62. doi: 10.1089/jwh.2021.0270. Epub 2022 Dec 1.
- Individual participant dataSharing planned: Undecided
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Parkinson Disease
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.
Caterina Trevisan, MD principal investigator
University of Padova, Geriatric Section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Parkinson Disease, run by University of Padova at 1 site in Italy.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Feb 2016. 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 Italy. 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.
Are results available for this study?
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?
Changes in resting energy expenditure (time frame: Baseline, week 4 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687698, which also lists 2 linked publications.
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 22 Feb 2016.