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

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: exercise program; Other: Modified Ketogenic Diet

• Registration Number: NCT06454162
• Lead Sponsor: Cairo University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Study Start: 2024-06-15
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise program	exercise program	thirty-two patients will receive an exercise program three times per week for three months
Modified Ketogenic Diet	exercise program	thirty-two patients will receive modified ketogenic diet and exercise program for three months
Modified Ketogenic Diet	Modified Ketogenic Diet	thirty-two patients will receive modified ketogenic diet and exercise program for three months

Primary Outcome Measures

Name	Time	Method
VO2 max	up to three months	VO2 max will be measured by cardiopulmonary exercise testing. Maximum level of oxygen consumption definite indicator of muscular work capacity Normal Range = 1,700 - 5,800 ml / min

Secondary Outcome Measures

Name	Time	Method
fatigue	up to three months	Modified Fatigue Impact Scale will be used to assess fatigue. participants rate on a 5-point Likert scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8).
Oxygen Consumption	up to three months	Oxygen Consumption will be measured by cardiopulmonary exercise testing. Normal = 250 ml / min 3.5 - 4 ml / min / kg, increases directly with the level of muscular work increases until exhaustion occurs and until individual reaches
Carbon Dioxide Production	up to three months	Carbon Dioxide Production will be assessed by cardiopulmonary exercise testing.Normal = 200 ml / min 2.8 ml / min / kg At Exercise: initial phase, increases at same rate as VO2, once Anaerobic Threshold (AT) is reached, increases at a faster rate than VO2; increase is due to increased acid production I
Anaerobic Threshold	up to three months	Anaerobic Threshold will be measured by cardiopulmonary exercise testing.Normal: occurs at about 60% of VO2 max, followed by breathlessness, burning sensation begins in working muscles.
Ventilatory Equivalent for Carbon Dioxide	up to three months	Ventilatory Equivalent for Carbon Dioxide will be measured by cardiopulmonary exercise testing.Minute ventilation / VCO2, to estimate Efficiency of ventilation and Liters of ventilation to eliminate 1 L of CO2.
exercise capacity	up to three months	six minute walk test will be used to assess the exercise capacity.
life disability	up to three months	Multiple sclerosis quality of life questionnaire will be used to assess life disability. MSQoL-54 scale scores were created using the Likert method by averaging items within the scales and, then row scores were linearly transformed into 0-100 scales. Higher values indicate better quality of life.
Ventilatory Equivalent for Oxygen	up to three months	Ventilatory Equivalent for Oxygen will be measured by cardiopulmonary exercise test. Minute ventilation / VO2, indicate Liters of ventilation per L of oxygen