| CTRI Number |
CTRI/2025/08/092576 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the Effectiveness of a Low Carbohydrate High Fat (LCHF) Diet on Tremor Severity and Mental Health in Patients with Essential Tremor – A Pilot Study
|
|
Scientific Title of Study
|
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 |
| Trial Acronym |
KETREM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujata Roshan |
| Designation |
Professor Department of Neurology |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research GIPMER |
| Address |
Department of Neurology Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Jawaharlal Nehru Marg Raj Ghat New Delhi India
Central
DELHI
110002
India |
| Phone |
8447761433 |
| Fax |
|
| Email |
drsujataroshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Roshan |
| Designation |
Professor, Department of Neurology |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research GIPMER |
| Address |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Jawaharlal Nehru Marg Raj Ghat New Delhi
Central
DELHI
110002
India |
| Phone |
8447761433 |
| Fax |
|
| Email |
drsujataroshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manvi Lamba |
| Designation |
MBBS graduate |
| Affiliation |
Maulana Azad Medical College New Delhi |
| Address |
Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9205977668 |
| Fax |
|
| Email |
manvilamba234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research GIPMER Jawaharlal Nehru Marg Raj Ghat New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manvi Lamba |
Department of Neurology Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research Jawaharlal Nehru Marg Raj Ghat New Delhi
Central
DELHI |
9205977668
manvilamba234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College (MAMC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G250||Essential tremor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Carbohydrate High Fat Diet |
Participants in the intervention group will follow a structured Low Carbohydrate High Fat dietary regimen for 4 weeks, planned and monitored by a certified dietician. The diet will restrict carbohydrates to 50 g per day while emphasizing high intake of fats and moderate protein.
|
| Comparator Agent |
Standard Diet
|
Participants in the control group will continue their usual diet without any specific modifications. Dietary intake will be monitored periodically for compliance and recorded.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in tremor severity using Fahn-Tolosa-Marin Tremor Rating Scale |
Baseline and 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in anxiety and depression scores using HADS |
Baseline and 6 weeks |
| Change in quality of life using QUEST |
Baseline and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
|