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

NCT06454162 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005184
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Modified Ketogenic Diet; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• exercise capacity

  up to three months

• fatigue

  up to three months

• life disability

  up to three months

• Oxygen Consumption

  up to three months

• Carbon Dioxide Production

  up to three months

Study Arms (2)

Modified Ketogenic Diet

EXPERIMENTAL

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

Other: Modified Ketogenic Diet; Other: exercise program

exercise program

ACTIVE COMPARATOR

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

Other: exercise program

Interventions

Modified Ketogenic Diet 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

Modified Ketogenic Diet

exercise program 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)

Modified Ketogenic Diet; exercise program

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator nabil mahmoud ismail abdel-aal

Model Details: Modified Ketogenic Diet and exercise program

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06