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IRCT20211020052826N2 IRCT 2026-10-07 Lorestan University Effect of Aquatic Exercise and Red Grape Juice Supplementation on Intestinal Permeability, Inflammation, and Neuromuscular Function in Women with Multiple Sclerosis Effects of an 8-Week Aquatic Training Program and Red Grape Juice Supplementation on Gut Permeability, Inflammatory Markers, and Neuromuscular Performance in Female Patients with Multiple Sclerosis 2026-11-05 anticipated 70 Recruiting https://irct.ir/trial/93859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomized parallel-group double-blind clinical trial (blinding of participants to the type of beverage, and blinding of outcome assessors and data analysts), with five intervention and control groups, Randomization description: Simple randomization was performed using a computer-generated random number sequence. Participants were allocated into five groups of 14. For allocation concealment, coded bottles were used, and only one person outside the data collection and analysis process had access to the allocation codes, Blinding description: In this study, blinding for the nutritional intervention (red grape juice supplement vs. placebo) has been fully implemented. Since there is no 'exercise-alone' group among the exercise groups, and both exercise groups receive a beverage (one supplement and one placebo), participants cannot distinguish whether their beverage is active or not. The supplement and placebo are completely identical in color, taste, volume, and packaging. Furthermore, outcome assessors and data analysts are blinded to the group allocation of the participants. Given the nature of the exercise intervention, blinding to 'performing exercise' is not feasible; however, this limitation has been compensated for by the precise blinding of assessors and analysts. N/A Relapsing-Remitting Multiple Sclerosis (RRMS). Intervention 1: Intervention group: Aquatic Exercise + Red Grape Juice Supplement. Intervention 2: Intervention group: Aquatic Exercise + Placebo. Intervention 3: Intervention group: Red Grape Juice Supplement without Exercise. Intervention 4: Intervention group: Placebo without Exercise. Intervention 5: Control group: Control Group (No Intervention). No - There is not a plan to make this available Justification or reason for not sharing IPD is Public sharing of Individual Participant Data (IPD) is not planned for this study. This decision is made to ensure the confidentiality of participants' personal information and to fully comply with the ethical principles outlined in the informed consent forms. The raw data will be used solely for the statistical analyses of this research and will remain accessible only to the research team.
public Amin Jalili Sarqaleh
No. 3, 1st Alley, Kalantari St., Lordegan, Chaharmahal and Bakhtiari, Iran
Lordegan Iran (Islamic Republic of) 8899156798 +98 38 3443 4312 aminjs0409@gmail.com Lorestan University scientific Amin Jalili Sarqaleh
No. 3, 1st Alley, Kalantari St., Lordegan, Chaharmahal and Bakhtiari, Iran
Lordegan Iran (Islamic Republic of) 8899156798 +98 38 3443 4312 aminjs0409@gmail.com Lorestan University Iran (Islamic Republic of) Women with Relapsing-Remitting Multiple Sclerosis (RRMS). Definitive diagnosis based on the 2017 revised McDonald criteria confirmed by a neurologist. Expanded Disability Status Scale (EDSS) score between 1 and 4.5. Ability to perform physical activity in water. No relapse in recent months. No severe cardiovascular, metabolic, or gastrointestinal diseases. No use of antioxidant supplements or regular exercise programs in the past three months. No known allergy to grape products. Willingness to participate and sign the written informed consent form. 20 years 40 years Female Relapse of the disease during the study. Any medication change during the study. Unwillingness to continue cooperation at any stage of the research. Having severe metabolic, cardiovascular, or gastrointestinal diseases. Consumption of new antioxidant supplements during the study. Performing exercise outside the study protocol. Smoking. G35 Multiple sclerosis Rehabilitation Rehabilitation Treatment - Other Placebo N/A Intervention group: Aquatic Exercise + Red Grape Juice Supplement Intervention group: Aquatic Exercise + Placebo Intervention group: Red Grape Juice Supplement without Exercise Intervention group: Placebo without Exercise Control group: Control Group (No Intervention) Lipopolysaccharide (LPS) level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by ELISA method. Zonulin level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by ELISA method. Interleukin-2 (IL-2) level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by ELISA method. Interleukin-10 (IL-10) level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by ELISA method. Tumor Necrosis Factor-alpha (TNF-α) level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by ELISA method. Cortisol level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by ELISA method. Stool acetate level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by Gas Chromatography (GC) method. Stool propionate level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by Gas Chromatography (GC) method. Stool butyrate level. Timepoint: All outcome variables are measured at two time points:Pre-test: 48 hours before the first intervention session Post-test: 48 hours after the last intervention session Blood sampling is performed after a 12-hour fast, between 8:00 and 9:00 AM. Method of measurement: Measurement by Gas Chromatography (GC) method. Nerve Conduction Velocity (EMG-NCV). Timepoint: Neuromuscular assessments including nerve conduction velocity (EMG-NCV), are performed at two time points: pre-test (48 hours before the first intervention session) and post-test (48 hours after the last intervention session). These assessments do not require fasting and are performed during standard daytime hours. Method of measurement: Electromyography and Nerve Conduction Velocity (EMG-NCV). Muscle strength. Timepoint: Neuromuscular assessments including muscle strength (dynamometer), are performed at two time points: pre-test (48 hours before the first intervention session) and post-test (48 hours after the last intervention session). These assessments do not require fasting and are performed during standard daytime hours. Method of measurement: Dynamometer. Balance. Timepoint: Neuromuscular assessments including balance (Stability Platform) are performed at two time points: pre-test (48 hours before the first intervention session) and post-test (48 hours after the last intervention session). These assessments do not require fasting and are performed during standard daytime hours. Method of measurement: Stability Platform. Personal Funds (PhD Thesis) Approved 2026-09-01 Research Ethics Committee (Sport Sciences Research Institute) No. 3, 5th Alley, Mir Emad St., Ostad Motahari St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)