Clinical Trial Radar

Subjective Sleep Quality Score

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), developed by psychiatrist Dr. Buysse in 1989. The PSQI includes seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, used sleep medication, and daytime dysfunction. Each component score ranges from 0 to 3, with a total score ranges from 0 to 21. Higher scores indicate poorer sleep quality, and a total score \>7 suggests clinically significant sleep impairment.

From enrollment to the end of intervention at 12 weeks

Chronotype

Chronotype will be evaluated using the Morningness-Eveningness Questionnaire (MEQ), a self-reported scale consisting of 19 items assessing physiological and behavioral preferences across a 24-hour cycle. MEQ-5 will be used in this trial, which scores range from 4 to 25, with higher scores indicating a morning-oriented chronotype and lower scores reflecting an evening-oriented preference.

From enrollment to the end of intervention at 12 weeks

Polysomnography

Polysomnography (PSG) is a comprehensive sleep assessment and the reference standard for objectively evaluating sleep physiology and sleep disorders. It records multiple signals during sleep, typically including electroencephalography, electrooculography, and electromyography, as well as respiratory airflow and effort, oxygen saturation, electrocardiography, and body position/limb movements, to characterize sleep stages, sleep architecture, and sleep-related events. PSG is commonly used to assess sleep-disordered breathing (e.g., obstructive sleep apnea), periodic limb movement disorder, and REM sleep behavior disorder. All PSG data in this study will be scored and analyzed according to American Academy of Sleep Medicine (AASM) guidelines.

From enrollment to the end of intervention at 12 weeks

Number of participants with abnormal blood and urine routine tests results

We will conduct blood routine and urine routine tests, and report the number of people with abnormal tests results. The tests indicators include: Red Blood Cell Count (RBC), Hemoglobin (Hb), Hematocrit (Hct), White Blood Cell Count (WBC), Neutrophils (Neut# and Neut%), Lymphocytes (Lym# and Lym%), Monocytes (Mono# and Mono%), Platelet Count (PLT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Urine Physical Characteristics (Appearance, specific gravity, pH), Urine Biochemical Analysis (Protein, Glucose, Occult blood, Leukocytes, Erythrocytes, and Bacteria). Any abnormal results will be marked on the laboratory report.

From enrollment to the end of intervention at 12 weeks

Homeostatic Model Assessment of Insulin Resistance

Plasma samples collected at different time points will be classified and labeled with two sets of each sample. An automated hematology analyzer in the hospital will be used.The degree of Insulin Resistance (IR) and sensitivity will be calculated by the Homeostatic Model Assessment (HOMA-IR) using the formula: HOMA-IR=(Fasting Insulin (μIU/mL) × Fasting Glucose (mmol/L) )/22.5

From enrollment to the end of intervention at 12 weeks

Frailty Assessment

Frailty status will be evaluated using the Fried Frailty Phenotype. The Fried Frailty Phenotype includes exhaustion, weight loss, low physical activity, slow gait speed, and grip strength measurement.For consistency with previous literature, participants who meet 3 or more criteria will be diagnosed as frailty, those who meet 1 or 2 criteria will be classified as prefrailty, and those who meet none of the criteria will be considered as nonfrailty.

From enrollment to the end of intervention at 12 weeks

Fatigue Severity Scale Score

The Fatigue Severity Scale will be used to measure the fatigue score of participants.Evaluates fatigue severity over the past week through 9 items, with each item scored from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 9 to 63. Higher scores indicate more severe fatigue.

From enrollment to the end of intervention at 12 weeks

Patient Health Questionnaire-9 Score

The Patient Health Questionnaire-9 (PHQ-9) is a brief self-report scale commonly used in clinical practice to assess depressive symptoms. It consists of 9 questions, primarily asking about the experience of depressive symptoms over the past two weeks and their frequency. Each response is set from 0 (not at all) to 3 (nearly every day), with a total score range of 0 to 27. Higher scores indicate more severe depressive symptoms.

From enrollment to the end of intervention at 12 weeks

Generalized Anxiety Disorder Scale Score

The Generalized Anxiety Disorder Scale (GAD-7) is a brief self-report scale used to assess anxiety symptoms over the past two weeks. It includes 7 questions, with responses rated from 0 to 3. The total score ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms.

From enrollment to the end of intervention at 12 weeks

Determination of Plasma Immunoglobulin Levels (g/L)

The levels of immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) in plasma samples will be measured using a fully automated biochemical analyzer, with all units expressed as g/L.

From enrollment to the end of intervention at 12 weeks

DNA Methylation Clock

The DNA methylation clock is an algorithm that integrates DNA methylation measurements across the genome to quantify biological age changes. It is considered a highly accurate molecular marker of human biological age. This clock can detect DNA methylation age reversal up to three months in advance, thus showing potential for quantifying biological aging, assessing expected lifespan, or evaluating the efficacy of interventions.

From enrollment to the end of intervention at 12 weeks

Profile of Mood States-Short Form (Chinese Version) Score

The Profile of Mood States-Short Form (Chinese Version) will be used to measure the energy score of participants. It measures energy levels using a 5-point scale ranging from 0 (never) to 4 (extremely), total score ranges from 0 to 160. Higher scores indicate greater vitality.

From enrollment to the end of intervention at 12 weeks

Plasma Interleukin Levels

Plasma interleukin levels are primarily used to reflect the inflammatory and immune status. In this study, the concentrations of interleukins (IL-1β, IL-6, IL-8, IL-10, IL-11, IL-33, IL-23R, and IL-17A) will be measured in fasting plasma samples of participants using ELISA kits, with units expressed as pg/mL. Notably, IL-11, IL-33, IL-23R, and IL-17A have recently gained attention as key molecules associated with aging.

From enrollment to the end of intervention at 12 weeks

Gut Microbiota Diversity Analysis (Based on 16S rRNA Gene Sequencing)

Stool samples (10g) from participants will be collected. These samples will be rapidly frozen in dry ice to stop metabolic reactions. DNA will be extracted from the frozen stool samples using the GNOME DNA isolation kit, and 16S rRNA sequencing will be performed using the IlluminaHiSeq2500 platform. 16S rRNA gene sequencing is a common method for analyzing the composition of the gut microbiota by high-throughput sequencing technology, widely used to assess the diversity and structural changes of the gut microbiota. The process includes DNA extraction from stool samples, amplification of specific regions of the 16S rRNA gene (such as the V3-V4 regions), and sequencing of the amplicons using a high-throughput sequencing platform (e.g., Illumina). Data quality control and microbiome structure analysis will be performed using bioinformatics tools (such as QIIME, Mothur and USEARCH) to assessing diversity.

From enrollment to the end of intervention at 12 weeks

D-lactic acid level

D-lactic acid level (μmol/L) in peripheral blood will be measured as an indicator of intestinal mucosal barrier integrity. Under physiological conditions, circulating D-lactic acid remains at trace concentrations in micromolar range. Elevated serum level reflects increased intestinal permeability due to mucosal damage from inflammation or ischemia, allowing bacterial-derived D-lactic acid to enter circulation.

From enrollment to the end of intervention at 12 weeks

NAD+ Level Measurement

Nicotinamide adenine dinucleotide (NAD+) plays a crucial role in cellular energy metabolism, redox reactions, and aging, which will be evaluated to monitor metabolic status and intervention efficacy. Methods include high-performance liquid chromatography (HPLC), mass spectrometry (MS), HPLC-MS/MS, and ELISA. Although ELISA has relatively lower accuracy, it is convenient to use. For this study commercial ELISA kits will be used.

From enrollment to the end of intervention at 12 weeks

Quality of Life Assessment

The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will be administered at baseline (week 0) and the end of intervention (week 12) to assess changes across four domains: physical health, psychological status, social relationships, and environmental factors. This instrument assesses the overall impact of the intervention on participants' quality of life.The standardized scores range from 0 to 100, with higher scores indicating a better quality of life.

From enrollment to the end of intervention at 12 weeks

Arterial stiffness assessment

Arterial stiffness will be assessed as a secondary outcome using an automated, noninvasive oscillometric vascular screening system. Bilateral brachial and ankle blood pressures and pulse waveforms will be recorded to derive brachial-ankle pulse wave velocity (baPWV) and the ankle-brachial index (ABI), along with peripheral blood pressure and heart rate, following standardized resting conditions and the manufacturer's recommended procedures.

From enrollment to the end of intervention at 12 weeks

Cardiopulmonary exercise testing

Cardiopulmonary exercise testing (CPET) will be conducted using an incremental, symptom-limited protocol on an electronically braked cycle ergometer. Participants will complete standardized pre-test screening and resting measurements, followed by a brief warm-up and stepwise increases in workload until volitional exhaustion or predefined termination criteria are met. Breath-by-breath gas exchange will be measured continuously to derive oxygen uptake (VO₂), carbon dioxide production (VCO₂), and minute ventilation (VE), alongside concurrent monitoring of heart rate, blood pressure, and electrocardiography. Key outcomes will include peak oxygen uptake (VO₂peak) and ventilatory threshold-based indices, with test procedures and interpretation aligned with established CPET guidelines.

From enrollment to the end of intervention at 12 weeks