An interventional study of Taurine supplementation and Placebo Supplementation in Obesity (Disorder) and Inflammation, sponsored by University of Sao Paulo. Not yet recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate whether taurine supplementation, alone or combined with high-intensity interval training (HIIT) performed in morning or evening, affects circadian clock gene expression and inflamatory markers in adult women with obesity. The main questions it aims to answer are:
Participants will:
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will not receive supplementation or participate in the exercise training program.
Participants will receive taurine supplementation without participating in the exercise training program.
Dietary Supplement: Taurine supplementation
Participants will receive taurine supplementation and perform high-intensity interval training (HIIT) in the morning
Dietary Supplement: Taurine supplementation · Behavioral: High-intensity interval training (HIIT)
Participants will receive taurine supplementation and perform HIIT in the evening.
Dietary Supplement: Taurine supplementation · Behavioral: High-intensity interval training (HIIT)
Participants will receive placebo capsules identical in appearance to the taurine capsules and perform HIIT in the morning.
Drug: Placebo Supplementation · Behavioral: High-intensity interval training (HIIT)
Participants will receive placebo capsules identical in appearance to the taurine capsules and perform HIIT in the evening.
Drug: Placebo Supplementation · Behavioral: High-intensity interval training (HIIT)
Taurine supplementation will be administered daily at a dose of 3g for 12 weeks, with participants taking three capsules containing 1g each. All participants will be instructed to take the three capsules in the morning. Daily adherence will be encouraged and monitored by the researcher responsible for the study through text messages and/or telephone calls. To ensure blinding and allocation concealment, the capsules and their containers will be identical in color, shape, and size.
Matching placebo capsules identical in appearance to the taurine capsules in color, shape, and size. Participants assigned to placebo groups will take three capsules daily in the morning for 12 weeks.
Supervised high-intensity interval training (HIIT) will be performed on a cycle ergometer three times per week for 12 weeks. Each session will last approximately 60 minutes and include a 5-minute low-intensity warm-up, vigorous exercise bouts at approximately 80% of peak oxygen uptake (VO₂peak), interspersed with 2.5-minute active recovery periods, and a 3-minute low-intensity cool-down. Training volume will progressively increase from three to six sets during the first four weeks, with six sets maintained through week 12. Exercise intensity will be monitored using heart rate (Polar® monitor) and ratings of perceived exertion (RPE). Sessions will be performed in the morning or evening, according to group assignment.
Changes in diurnal variation of BMAL1 gene expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of CLOCK gene expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of PER genes expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of CRY genes expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of NR1D1 gene expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in BMAL1 protein expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in CLOCK protein expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in PER proteins expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in CRY proteins expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in NR1D1 protein expression in peripheral blood mononuclear cells (PBMCs)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in serum cytokines concentrations
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in cytokines concentrations in peripheral blood mononuclear cells (PBMCs) culture supernatants under basal and LPS-stimulated conditions
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in NF-κB, NLRP3 and cleaved caspase-1 (p20) proteins expression in peripheral blood mononuclear cells (PBMC) culture supernatants
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in glycemic profile, including fasting blood glucose, fasting insulin and insulin resistance
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in lipidic profile, including total cholesterol, HDL and LDL cholesterol and triglycerides
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in body weight and body mass index (BMI)
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).
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in waist and hip circumferences
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).
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in body composition parameters
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).
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in peak oxygen uptake (VO₂peak)
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.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in maximal heart rate
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).
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in plasma taurine concentrations
Changes in plasma taurine concentrations will be assessed before and after interventions using high-performance liquid chromatography (HPLC). Results will be expressed as µmol/L.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in dietary intake
Changes in dietary intake, including total energy, macronutrients and micronutrients intake will be estimated before and after interventions using three-day dietary records collected on two non-consecutive weekdays and one weekend day. Participants will be instructed to record in detail all foods and beverages consumed at each meal over a 24-hour period. Energy intake will be expressed in kilocalories per day (kcal/day). Carbohydrates and lipid intake will be expressed as percentage of total energy intake (%). Protein will be expressed as grams per kilograms of body weight per day (g/kg/day). Micronutrients will be expressed in the appropriate units for each nutrient. All the estimates will be performed using NutrabemPro® software.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in Peripheral Blood Mononuclear Cell (PBMC) Subpopulations
Changes in PBMC subpopulations will be assessed before and after the interventions using flow cytometry. The following cell populations will be analyzed: T lymphocytes (CD3+), CD4+ T lymphocytes (CD3+CD4+), CD8+ T lymphocytes (CD3+CD8+), B lymphocytes (CD19+), and classical (CD14++CD16-), intermediate (CD14++CD16+), and non-classical (CD14+CD16++) monocytes. Results will be expressed as the percentage of the corresponding parent cell population, according to the flow cytometry gating strategy.
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Plan to share: No
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