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

NCT ID: NCT06454162

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2024-12-30

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Modified Ketogenic Diet

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

Group Type: EXPERIMENTAL

Modified Ketogenic Diet

Intervention Type: OTHER

the patients will receive KD after nutritional counseling, patients will instructed to start by limiting carbohydrate intake to just 20 g/day for 4 weeks in order to establish ketosis. Then, patients increase their carbohydrate intake by 5 g each week until they reach their individual maximum (approximately 40 g) to maintain stable ketosis. All carbohydrates relevant for elevating blood glucose are limited to 40-50 g/ day. In addition, the glycemic index and glycemic load of carbohydrates have to be below 50 and 60, respectively. This ketogenic diet is equivalent to a traditional ketogenic diet, but with a liberalized macronutrient composition of 70-80% fats, 15-20% proteins and 5-10% carbohydrates (compared to a traditional ketogenic diet with 90% fat, 6% proteins and 4% carbohydrates)+ exercise program

exercise program

Intervention Type: OTHER

the patients will receive exercise program in the form of aerobic training (10-30 minutes at moderate intensity) and resistance training (1-3 sets of 8-15 repetition maximum (RM)

exercise program

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

Group Type: ACTIVE_COMPARATOR

exercise program

Intervention Type: OTHER

the patients will receive exercise program in the form of aerobic training (10-30 minutes at moderate intensity) and resistance training (1-3 sets of 8-15 repetition maximum (RM)

Interventions

Modified Ketogenic Diet

the patients will receive KD after nutritional counseling, patients will instructed to start by limiting carbohydrate intake to just 20 g/day for 4 weeks in order to establish ketosis. Then, patients increase their carbohydrate intake by 5 g each week until they reach their individual maximum (approximately 40 g) to maintain stable ketosis. All carbohydrates relevant for elevating blood glucose are limited to 40-50 g/ day. In addition, the glycemic index and glycemic load of carbohydrates have to be below 50 and 60, respectively. This ketogenic diet is equivalent to a traditional ketogenic diet, but with a liberalized macronutrient composition of 70-80% fats, 15-20% proteins and 5-10% carbohydrates (compared to a traditional ketogenic diet with 90% fat, 6% proteins and 4% carbohydrates)+ exercise program

Intervention Type: OTHER

exercise program

the patients will receive exercise program in the form of aerobic training (10-30 minutes at moderate intensity) and resistance training (1-3 sets of 8-15 repetition maximum (RM)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nabil Mahmoud Ismail Abdel-Aal

principle investigator nabil mahmoud ismail abdel-aal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/012/005184

Identifier Type: -

Identifier Source: org_study_id