Clinical trial NCT06454162: Effect of Adding Modified Ketogenic Diet to Exercise Program in Treating Obese Patient With Multiple Sclerosis: A Randomized Controlled Trial
Official title: Effect of Adding Modified Ketogenic Diet to Exercise Program in Treating Obese Patient With Multiple Sclerosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Modified Ketogenic Diet
Multiple Sclerosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Modified Ketogenic Diet and exercise program
Primary purpose: TREATMENT

Brief summary: this study will be conducted to investigate the effect of adding Modified Ketogenic diet to exercise program in treating obese patient with multiple sclerosis.

Detailed description: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. Ketone bodies that are produced during fasting diets (FDs) and ketogenic diets (KDs) are an alternative and presumably more efficient energy source for the brain.Ketogenic diets (KDs) are high-fat, low-carbohydrate diets that mimic a fasting state. KDs create a metabolic shift from glycolytic energy production toward oxidative phosphorylation energetics by using fatty acids as a primary source of energy. As these fatty acids undergo beta-oxidation, ketones are produced. This increase in oxidative phosphorylation coupled with ketone production modifies the tri carboxylic acid cycle to limit reactive oxygen species generation. In addition, ketone bodies transported across the blood-brain barrier up regulate antioxidant pathway genes (particularly via the Nrf2 pathway) and boost energy production in brain tissue.sixty-four subjects with MS, ranged from 18-50 years. will be selected randomly divided into two groups each group consists of thirty-two subjects; experimental group (modified ketogenic diet+ aerobic exercise) and control group (aerobic exercise).

Eligibility criteria: Inclusion Criteria:

* Confirmed MS based on McDonald Criteria.
* Patients had to be fully ambulatory, not requiring assistive devices.
* The ages of 18 and 50
* Patients Body mass index (BMI) less than 30 Kg/m2.

Exclusion Criteria:

* Evidence of active disease or relapse phase within the last 30 days
* Chronic heart failure, cancer, chronic kidney disease, infection with human Immunodeficiency
* Addiction to drugs or alcohol.
* Pregnancy and Diabetic patient.

Primary outcomes:
measure: VO2 max
timeFrame: up to three months
Secondary outcomes:
measure: exercise capacity
timeFrame: up to three months
measure: fatigue
timeFrame: up to three months
measure: life disability
timeFrame: up to three months
measure: Oxygen Consumption
timeFrame: up to three months
measure: Carbon Dioxide Production
timeFrame: up to three months
measure: Anaerobic Threshold
timeFrame: up to three months
measure: Ventilatory Equivalent for Carbon Dioxide
timeFrame: up to three months
measure: Ventilatory Equivalent for Oxygen
timeFrame: up to three months
Other outcomes:
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