Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06715436

Effects of Ketogenic Diet vs Mediterranean Diet on Quality of Life in Multiple Sclerosis Patients A Randomized Controlled Pilot Study

Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-12-20

111

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

I

IRCCS National Neurological Institute "C. Mondino" Foundation

Lead Sponsor

U

University of Pavia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Multiple sclerosis (MS) is a neurological disease caused by inflammation and immune system problems, influenced by both genetic and environmental factors. Researchers are studying how different diets might affect MS risk and progression. The Mediterranean diet has been linked to a lower risk of developing MS and less severe symptoms compared to other diets. Ketogenic diets, which severely limit carbohydrates to promote ketone production, have shown promising results in animal studies and small human trials by slowing disease progression and improving symptoms in MS patients. This study compares the effects of two diets on quality of life in people with MS: a modified Atkins ketogenic diet that limits carbohydrates to 20 grams per day, and a Mediterranean diet based on traditional food guidelines. A control group will continue their usual diet and lifestyle. The study is designed as a three-arm, randomized pilot trial to evaluate these dietary patterns over six months. Participants will follow their assigned diets while researchers monitor health outcomes. Participants will be assessed at the start and after six months using the physical health subscale of the Multiple Sclerosis Quality of Life-54 questionnaire. Monthly phone interviews will check diet adherence, supplement use, physical activity, and nutrition habits. Other measures include neurological, nutritional, motor, and clinical outcomes to evaluate safety, feasibility, and overall effects of the diets during the study period.

CONDITIONS

Official Title

Multiple Sclerosis and the Effects of Ketogenic Diet Therapy

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS)
  • Age between 18 and 60 years
  • BMI between 18.5 kg/m2 and 39.9 kg/m2
  • If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months
  • Ability to give verbal and written consent
Not Eligible

You will not qualify if you...

  • Actively engaged in a weight loss program or other specific diet (e.g., vegetarian, vegan)
  • Not willing to follow the assigned dietary pattern or high adherence to Mediterranean diet (MediLite score > 14)
  • Pregnancy or breastfeeding
  • Relapse or cortisone treatment within 30 days before study entry
  • Clinically relevant metabolic, progressive or malignant diseases
  • Intake of > 1 g/day of omega-3 fatty acid supplements
  • Underweight (BMI < 18.5 kg/m2) or severe obesity
  • Significant cognitive-cooperative impairment
  • Insulin-dependent diabetes mellitus (type I)
  • Weight loss greater than 5 kg within 2 months prior to study entry
  • Diagnosis or suspicion of an eating disorder
  • Kidney stones
  • Oral anticoagulant therapy
  • Known alcohol and drug abuse

AI-Screening

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Trial Site Locations

Total: 1 location

1

U.O.Sclerosi Multipla

Pavia, Italy, 27100

Actively Recruiting

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Research Team

E

Eleonora Tavazzi, MD

C

Cinzia Fattore, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Insulin resistance is associated with cognitive dysfunction in multiple sclerosis patients: A cross-sectional study.

Hormoz Ayromlou, Samaneh Hosseini, Mohammad Khalili...

https://pubmed.ncbi.nlm.nih.gov/37317829

A healthy dietary pattern associates with a lower risk of a first clinical diagnosis of central nervous system demyelination.

Lucinda J Black, Charlotte Rowley, Jill Sherriff...

https://pubmed.ncbi.nlm.nih.gov/30084751

Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits.

J Nicholas Brenton, Diana Lehner-Gulotta, Emma Woolbright...

https://pubmed.ncbi.nlm.nih.gov/35418509

Genetic risk and a primary role for cell-mediated immune mechanisms in multiple sclerosis.

International Multiple Sclerosis Genetics Consortium, Wellcome Trust Case Control Consortium 2, Stephen Sawcer...

https://pubmed.ncbi.nlm.nih.gov/21833088