Multiple SclerosisMSNCT06454162
Effect of Adding Modified Ketogenic Diet to Exercise Program in Treating Obese Patient With Multiple Sclerosis: A Randomized Controlled Trial
A study testing Modified Ketogenic Diet and exercise program in people with Multiple Sclerosis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Modified Ketogenic Diet and exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
this study will be conducted to investigate the effect of adding Modified Ketogenic diet to exercise program in treating obese patient with multiple sclerosis.
Read the 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
- Being tested
- Modified Ketogenic Diet, exercise program
- Keywords
- Modified Ketogenic Diet, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Ketogenic DietOther
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 programOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Modified Ketogenic Diet | Experimental | thirty-two patients will receive modified ketogenic diet and exercise program for three months Receives: 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 Receives: Other: exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to three months
Secondary outcomes (8)
exercise capacity
six minute walk test will be used to assess the exercise capacity.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Modified Ketogenic Diet and exercise program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454162
- Sponsor's protocol ID
- P.T.REC/012/005184
- Acronym
- MS
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Modified Ketogenic Diet to Exercise Program in Treating Obese Patient With Multiple Sclerosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06454162
- Acronym / sponsor ID
- MS / P.T.REC/012/005184
- Conditions
- Multiple Sclerosis
- Keywords
- Modified Ketogenic Diet, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Modified Ketogenic Diet and exercise program
| Arm | Type | Receives |
|---|---|---|
| Modified Ketogenic Diet | Experimental | Other: Modified Ketogenic Diet, Other: exercise programthirty-two patients will receive modified ketogenic diet and exercise program for three months |
| exercise program | Active comparator | Other: exercise programthirty-two patients will receive an exercise program three times per week for three months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Ketogenic Dietthe 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 | Modified Ketogenic Diet |
| exercise programthe 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) | Other | Modified Ketogenic Diet, exercise program |
Primary outcome
VO2 max
Time frame: 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
8 secondary outcomes
exercise capacity
Time frame: up to three months
fatigue
Time frame: up to three months
life disability
Time frame: up to three months
Oxygen Consumption
Time frame: up to three months
Carbon Dioxide Production
Time frame: up to three months
Anaerobic Threshold
Time frame: up to three months
Ventilatory Equivalent for Carbon Dioxide
Time frame: up to three months
Ventilatory Equivalent for Oxygen
Time frame: up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Ketogenic Diet and exercise program in people with Multiple Sclerosis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.