跳至主要内容
临床试验/NCT06454162
NCT06454162尚未招募不适用

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

Cairo University0 个研究点目标入组 64 人开始时间: 2024年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
VO2 max

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

opaque sealed envelope

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

VO2 max

时间窗: 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

次要结局

  • fatigue(up to three months)
  • Oxygen Consumption(up to three months)
  • Carbon Dioxide Production(up to three months)
  • Anaerobic Threshold(up to three months)
  • Ventilatory Equivalent for Carbon Dioxide(up to three months)
  • exercise capacity(up to three months)
  • life disability(up to three months)
  • Ventilatory Equivalent for Oxygen(up to three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nabil Mahmoud Ismail Abdel-Aal

principle investigator nabil mahmoud ismail abdel-aal

Cairo University

相似试验