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Trial · NCT07910747

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryChanges in diurnal variation of BMAL1 gene expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Diurnal variation in BMAL1 gene expression will be assessed in PBMCs before and after interventions using quantitative polymerase chain reaction (qPCR). Gene expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples, and diurnal variation will be calculated as the difference between evening and morning relative gene expression levels.
SecondaryChanges in diurnal variation of CLOCK gene expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Diurnal variation in CLOCK gene expression will be assessed in PBMCs before and after interventions using quantitative polymerase chain reaction (qPCR). Gene expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples, and diurnal variation will be calculated as the difference between evening and morning relative gene expression levels.
SecondaryChanges in diurnal variation of PER genes expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Diurnal variation in PER1 and PER2 genes expression will be assessed in PBMCs before and after interventions using quantitative polymerase chain reaction (qPCR). Gene expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples, and diurnal variation will be calculated as the difference between evening and morning relative gene expression levels.
SecondaryChanges in diurnal variation of CRY genes expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Diurnal variation in CRY1 and CRY2 genes expression will be assessed in PBMCs before and after interventions using quantitative polymerase chain reaction (qPCR). Gene expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples, and diurnal variation will be calculated as the difference between evening and morning relative gene expression levels.
SecondaryChanges in diurnal variation of NR1D1 gene expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Diurnal variation in NR1D1 gene expression will be assessed in PBMCs before and after interventions using quantitative polymerase chain reaction (qPCR). Gene expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples, and diurnal variation will be calculated as the difference between evening and morning relative gene expression levels.
SecondaryChanges in BMAL1 protein expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Changes in BMAL1 protein expression in PBMCs will be assessed before and after the intervention using Western Blotting. Protein expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples by densitometric analysis.
SecondaryChanges in CLOCK protein expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Changes in CLOCK protein expression in PBMCs will be assessed before and after the intervention using Western Blotting. Protein expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples by densitometric analysis.
SecondaryChanges in PER proteins expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Changes in PER1 and PER2 proteins expression in PBMCs will be assessed before and after the intervention using Western Blotting. Protein expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples by densitometric analysis.
SecondaryChanges in CRY proteins expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Changes in CRY1 and CRY2 proteins expression in PBMCs will be assessed before and after the intervention using Western Blotting. Protein expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples by densitometric analysis.
SecondaryChanges in NR1D1 protein expression in peripheral blood mononuclear cells (PBMCs)Baseline (Week 0) and post-intervention (Week 12).
Changes in NR1D1 protein expression in PBMCs will be assessed before and after the intervention using Western Blotting. Protein expression will be quantified in morning (7:00 AM) and evening (7:00 PM) samples by densitometric analysis.
SecondaryChanges in serum cytokines concentrationsBaseline (Week 0) and post-intervention (Week 12).
Changes in serum tumor necrosis factor-alpha (TNF-α), interleucin-6 (IL-6), IL-10, IL-1β concentrations will be assessed before and after interventions using the MILLIPLEX® Human Cytokine/Chemokine/Growth Factor Panel A (Merck Millipore, EMD Millipore Corporation, Billerica, MA, USA), according to the manufacturer's instructions. Results will be expressed in pg/mL.
SecondaryChanges in cytokines concentrations in peripheral blood mononuclear cells (PBMCs) culture supernatants under basal and LPS-stimulated conditionsBaseline (Week 0) and post-intervention (Week 12).
Changes in tumor necrosis factor-alpha (TNF-α), interleucin-6 (IL-6), IL-10, IL-1β concentrations in PBMC culture supernatants will be assessed under basal and lipopolysaccharide (LPS)-stimulated conditions before and after the interventions. Results will be expressed in pg/mL.
SecondaryChanges in NF-κB, NLRP3 and cleaved caspase-1 (p20) proteins expression in peripheral blood mononuclear cells (PBMC) culture supernatantsBaseline (Week 0) and post-intervention (Week 12).
Changes in NF-κB, NLRP3 and cleaved caspase-1 (p20) proteins expression in PBMC culture supernatants will be assessed before and after the intervention using Western Blotting. Protein expression will be quantified by densitometric analysis. Results will be expressed as relative protein expression.
SecondaryChanges in glycemic profile, including fasting blood glucose, fasting insulin and insulin resistanceBaseline (Week 0) and post-intervention (Week 12).
Changes in fasting blood glucose and insulin concentrations will be assessed before and after the interventions using an enzymatic method with commercial glucose assay kits (Labtest Diagnóstica®) and spectrophotometric absorbance measurements. Results will be expressed in mg/dL. Insuline resistance will be assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting blood glucose and insulin concentrations according to the specified calculation method. Results will be reported as HOMA-IR values.
SecondaryChanges in lipidic profile, including total cholesterol, HDL and LDL cholesterol and triglyceridesBaseline (Week 0) and post-intervention (Week 12).
Changes in total cholesterol, high-density lipoprotein cholesterol (HDL-c) concentrations will be assessed using an enzymatic method with commercial assay kits (Colesterol Total Liquiform, Colesterol HDL, Labtest Diagnóstica®) and spectrophotometric absorbance measurements. Changes in triglycerides concentrations will be assessed using an enzymatic method with commercial assay. Changes in low-density lipoprotein cholesterol (LDL-c) concentrations will be calculated using the Friedewald formula based on total cholesterol, HDL-c, and triglyceride concentrations. All these parameters will be assessed before and after the intervention and all the results will be expressed in mg/dL.
SecondaryChanges in body weight and body mass index (BMI)Baseline (Week 0) and post-intervention (Week 12).
Changes in body weight and BMI will be assessed before and after the interventions. Body weight will be assessed using a calibrated digital scale, and results will be expressed in kilograms (kg). BMI will be calculated as body weight in kilograms divided by the square of height in meters (kg/m²).
SecondaryChanges in waist and hip circumferencesBaseline (Week 0) and post-intervention (Week 12).
Changes in waist and hip circumferences will be assessed before and after the interventions using a non-elastic anthropometric measuring tape. Measurements will be performed according to standardized anthropometric procedures, with results expressed in centimeters (cm).
SecondaryChanges in body composition parametersBaseline (Week 0) and post-intervention (Week 12).
Changes in total body fat, visceral adipose tissue and lean mass will be assessed before and after the interventions using dual-energy X-ray absorptiometry (DXA). Total body fat will be expressed as a percentage (%) of total body mass. Visceral adipose tissue will expressed in grams (g). Lean mass will be expressed in kilograms (kg).
SecondaryChanges in peak oxygen uptake (VO₂peak)Baseline (Week 0) and post-intervention (Week 12).
Changes in peak oxygen uptake (VO₂peak) will be assessed before and after the interventions using an incremental cycle ergometer test. Respiratory gas exchange will be measured using a QUARK cardiopulmonary exercise testing system. Results will be expressed in mL/kg/min.
SecondaryChanges in maximal heart rateBaseline (Week 0) and post-intervention (Week 12).
Changes in maximal heart rate will be assessed before and after the interventions during an incremental cycle ergometer test. Heart rate will be monitored using a Polar heart rate monitor. Results will be expressed in beats per minute (bpm).

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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