Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease

NCT02687698 | Unknown

• 1 other identifier: 3575/AO/15
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Changes in resting energy expenditure

  Changes in resting energy expenditure as measured by indirect calorimetry

  Baseline, week 4 and week 8

Study Arms (2)

Ketogenic diet

EXPERIMENTAL

Patients will be suggested to follow a ketogenic diet for 8 weeks.

Other: Ketogenic diet

Control

NO INTERVENTION

Usual diet.

Interventions

Ketogenic diet OTHER

The proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins.

Ketogenic diet

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• diabetes mellitus;
• dysphagia;
• dementia;
• dyslipidemia;
• history of recent cardiovascular or cerebrovascular events;
• psychiatric diseases;
• iatrogen parkinsonism.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Geriatric Section

Padua, Padova, 35128, Italy

Location

Related Publications (2)

• 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.

  PMID: 15728303 RESULT

• Shehu 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.

  PMID: 36459629 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Caterina Trevisan, MD

  University of Padova, Geriatric Section

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

IT (1)