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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Modified Ketogenic Diet; Other: exercise program

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).

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Ketogenic Diet; thirty-two patients will receive modified ketogenic diet and exercise program for three months	Other: 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; 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)
Active Comparator: exercise program; thirty-two patients will receive an exercise program three times per week for three months	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	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	up to three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise capacity	six minute walk test will be used to assess the exercise capacity.	up to three months
fatigue	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).	up to three months
life disability	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.	up to three months
Oxygen Consumption	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	up to three months
Carbon Dioxide Production	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	up to three months
Anaerobic Threshold	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.	up to three months
Ventilatory Equivalent for Carbon Dioxide	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.	up to three months
Ventilatory Equivalent for Oxygen	Ventilatory Equivalent for Oxygen will be measured by cardiopulmonary exercise test. Minute ventilation / VO2, indicate Liters of ventilation per L of oxygen	up to three months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Modified Ketogenic Diet
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: P.T.REC/012/005184

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No