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Trial · NCT07914270

Registered outcomes43

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryChange in Oxidative stress biomarkers (Glutathione Peroxidase Activity)Pre and post-intervention of 16 weeksGlutathione peroxidase (GPx) activity will be measured from blood samples as a marker of antioxidant defense.
SecondaryChange in Immune system (Total Leukocyte Count)Pre and post-intervention of 16 weeksTotal circulating leukocyte count will be measured from peripheral blood samples to assess changes in overall immune cell status
SecondaryChange in Immune system (Neutrophil Count)Pre and post-intervention of 16 weeksCirculating neutrophil count will be measured from peripheral blood samples to assess changes in the neutrophil component of the immune response
SecondaryChange in Immune system (Lymphocyte Count)Pre and post-intervention of 16 weeksCirculating lymphocyte count will be measured from peripheral blood samples to assess changes in the lymphocyte component of immune function
SecondaryChange in Immune system (Monocyte Count)Pre and post-intervention of 16 weeksCirculating monocyte count will be measured from peripheral blood samples to assess changes in this component of the innate immune system
SecondaryChange in Immune system (Eosinophil Count)Pre and post-intervention of 16 weeksCirculating eosinophil count will be measured from peripheral blood samples to assess changes in this leukocyte population
SecondaryChange in Immune system (Basophil Count)Pre and post-intervention of 16 weeksCirculating basophil count will be measured from peripheral blood samples to assess changes in this leukocyte population
SecondaryChange in Immune system (Platelet Count)Pre and post-intervention of 16 weeksCirculating platelet count will be measured from peripheral blood samples to assess changes in platelet levels
SecondaryChange in Immune system (Neutrophil-to-Lymphocyte Ratio)Pre and post-intervention of 16 weeks
The neutrophil-to-lymphocyte ratio (NLR) will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. NLR will be used as an integrated hematological marker of systemic inflammatory and immune status.
SecondaryChange in Immune system (Systemic Immune-Inflammation Index )Pre and post-intervention of 16 weeksThe Systemic Immune-Inflammation Index (SII) will be calculated from peripheral blood platelet, neutrophil, and lymphocyte counts as an integrated marker of systemic immune-inflammatory status.
SecondaryChange in Neurobiological function (Brain-Derived Neurotrophic Factor concentration)Pre and post-intervention of 16 weeksCirculating brain-derived neurotrophic factor (BDNF) concentration will be measured from blood samples to assess changes in a neurotrophic factor involved in neuronal function and neuroplasticity .
SecondaryChange in Cognitive function (Trail Making Test Part A Completion Time)Pre and post-intervention of 16 weeks
Cognitive performance will be assessed using the Trail Making Test Part A (TMT-A), which primarily evaluates visual attention, processing speed, and visuomotor tracking. Participants will be instructed to connect numbered targets sequentially as quickly and accurately as possible. Completion time will be recorded in seconds, with lower completion times indicating better performance.
SecondaryChange in Cognitive function (Trail Making Test Part B Completion Time)Pre and post-intervention of 16 weeks
Executive and attentional performance will be assessed using the Trail Making Test Part B (TMT-B), which requires participants to alternate sequentially between numbered and lettered targets. The test primarily assesses cognitive flexibility, set-shifting, divided attention, and executive function. Completion time will be recorded in seconds, with lower completion times indicating better performance.
OtherChange in WHOQOL-OLD ScorePre and post-intervention of 16 weeks
Quality of life in older adults will be assessed using the World Health Organization Quality of Life-OLD (WHOQOL-OLD) questionnaire, which evaluates relevant dimensions of quality of life specifically related to older populations. Changes in questionnaire scores will be used to assess the effect on perceived quality of life.
OtherChange in Health-Related Quality of Life Assessed by the EQ-5D-5LPre and post-intervention of 16 weeks
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The instrument evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Changes in EQ-5D-5L health status will be used to assess the effect on perceived health-related quality of life.
OtherChange in Pittsburgh Sleep Quality Index ScorePre and post-intervention of 16 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates different aspects of sleep over the preceding month. Changes in the global PSQI score will be used to assess sleep quality, with higher scores indicating poorer sleep quality
OtherChange in Depressive symptomsPre and post-intervention of 16 weeks
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Changes in the total score will be used to assess depressive symptom severity, with higher scores indicating greater severity of depressive symptoms.
OtherChange in FatiguePre and post-intervention of 16 weeks
Fatigue will be assessed using the 10-item Fatigue Assessment Scale (FAS). Each item is rated on a five-point response scale ranging from 1 (never) to 5 (always). Changes in the total FAS score will be used to assess perceived fatigue, with higher scores indicating greater fatigue.
OtherChange in Affective StatePre and post-intervention of 16 weeks
Positive affect will be assessed using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS). The PANAS comprises 20 affect-related items rated on a five-point response scale. Changes in the Positive Affect subscale score will be used to assess changes in positive emotional state, with higher scores indicating greater positive affect.
OtherChange in Serum CreatininePre and post-intervention of 16 weeksSerum creatinine concentration will be assessed as a clinical safety marker related to renal function.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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