A Pilot Randomized Controlled Trial to Evaluate the Effectiveness of a Low Carbohydrate High Fat Diet on Tremor Severity and Mental Health Outcomes in Patients with Essential Tremor
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Self funded
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in tremor severity using Fahn-Tolosa-Marin Tremor Rating Scale
Overview
Brief Summary
This pilot study evaluates the effectiveness of a Low Carbohydrate High Fat LCHF diet also known as the ketogenic diet on tremor severity anxiety depression and quality of life in patients with Essential Tremor ET
Essential Tremor is a common neurological disorder that causes involuntary shaking especially in older adults Current treatments including medications and surgery have several limitations This has led to growing interest in noninvasive alternatives
The LCHF diet is known for its neuroprotective and antiinflammatory effects in neurological conditions such as epilepsy and Parkinson disease It is believed to influence neurotransmitters like GABA which play a role in the development of Essential Tremor
This study is conducted at GIPMER New Delhi and involves 50 adult ET patients Participants are randomly assigned to either a structured LCHF diet or standard care for a period of six weeks Assessments are conducted at the beginning and end of the study using validated tools Fahn Tolosa Marin Scale for tremor Hospital Anxiety and Depression Scale HADS and Quality of Life in Essential Tremor Questionnaire QUEST
Weekly followups are included to monitor diet adherence safety and side effects The study is ethically sound and low risk with minor side effects like nausea and fatigue being anticipated The design is prospective randomized and uses appropriate statistical methods for analysis
If effective the findings could support larger trials and promote dietary strategies as a safe and accessible treatment for patients with Essential Tremor
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosis of Essential Tremor Age above 18 years Willingness to follow LCHF dietary plan Able to provide informed consent Not currently on any specific diet.
Exclusion Criteria
- •Age less than 18 years Pregnancy or breastfeeding History of diabetes, liver or kidney disease History of pancreatitis or gallstones Severe psychiatric illness Currently following an LCHF or ketogenic diet • Participation in another clinical trial.
Outcomes
Primary Outcomes
Change in tremor severity using Fahn-Tolosa-Marin Tremor Rating Scale
Time Frame: Baseline and 6 weeks
Secondary Outcomes
- Change in anxiety and depression scores using HADS(Baseline and 6 weeks)
- Change in quality of life using QUEST(Baseline and 6 weeks)
Investigators
Dr Sujata Roshan
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research GIPMER