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Study aim:
The purpose of this study is to investigate the effect of 6 weeks of aerobic training and royal jelly consumption on total antioxidant capacity and glutathione peroxidase in patients with multiple sclerosis.
Design:
A clinical trial with the control group, parallel, single-blind, randomized, with a predicted sample size of 60 and Phase 3 trial
Settings and conduct:
This study will be performed on multiple sclerosis patients living in Zahedan, Iran. The duration of the research is 6 weeks and the participants are divided into four groups randomly. Single-blind blindness will be performed in order to avoid the bias of the subjects and the researcher and the impact on the research results. Two interventional factors including exercise and Royal jelly are considered for this study.
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
Multiple sclerosis patients: Expanded Disability Status Scale (EDSS) between 0-4
No supplement
No cardiovascular disease
Exclusion criteria:
Non- multiple sclerosis Patients
Multiple sclerosis patients: EDSS more than 4
Use of pharmaceutical supplements
Cardiovascular disease
Intervention groups:
First intervention group: Exercise and Royal jelly; Aerobic exercise and Royal jelly have been selected as interventionists of this group.
Second intervention group: Exercise and placebo; Aerobic exercise has been selected as the intervention of this group. Of course, the placebo will also be used.
Third intervention group: Royal jelly. In this group, Royal jelly is an intervention agent.
Control group: Placebo; The placebo will be used in the control group.
Main outcome variables:
Study of total antioxidant capacity changes; Study of Glutathione Peroxidase Changes