Effect of Adding Modified Ketogenic Diet to Exercise Program in Treating Obese Patient With Multiple Sclerosis: A Randomized Controlled Trial (MS)

Cairo University (CU)

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Modified Ketogenic Diet; Other: exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06454162

P.T.REC/012/005184

Details and patient eligibility

About

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

Full 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).

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Modified Ketogenic Diet

Experimental group

Description:

thirty-two patients will receive modified ketogenic diet and exercise program for three months

Treatment:

Other: exercise program

Other: Modified Ketogenic Diet

exercise program

Active Comparator group

Description:

thirty-two patients will receive an exercise program three times per week for three months

Treatment:

Other: exercise program