Obesity (Disorder)NCT07910747
Effects of Taurine Supplementation and Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity
A study testing Taurine supplementation and High-intensity interval training (HIIT) in people with Obesity (Disorder) and Inflammation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity (Disorder), Inflammation
- What is being tested?
- Taurine supplementation and High-intensity interval training (HIIT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2027to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Have a body mass index (BMI) of 30-39.9 kg/m² (class I or II obesity) for at least 3 years and a body fat percentage ≥35%;
- Have maintained stable body weight during the 3 months preceding the study;
- Have a predominantly nocturnal sleep schedule and no history of night-shift or rotating-shift work during the previous 6 months;
- Have not participated in structured exercise training programs or undertaken restrictive diets or other nutritional interventions during the 3 months preceding the study;
- Have serum high-sensitivity C-reactive protein (hs-CRP) levels >1 and <10 mg/L, consistent with low-grade systemic inflammation, in the absence of clinical or laboratory evidence of infection or an acute inflammatory process.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Have hs-CRP levels ≥10 mg/L;
- Present signs or symptoms suggestive of infection or an acute inflammatory process, including fever, flu-like symptoms, recent infections, use of antibiotics or anti-inflammatory medications, or recent vaccination;
- Have a diagnosed chronic inflammatory disease or have experienced an acute infectious process within the 2 weeks preceding the assessments;
- Have insulin-dependent diabetes mellitus, established cardiovascular disease, uncontrolled hypertension, or clinically significant sleep disorders;
- Regularly use medications such as immunosuppressants, glucose-lowering agents, corticosteroids, or anti-inflammatory drugs;
- Are current smokers or chronic alcohol users;
- Attendance at fewer than 80% of the scheduled training for participants allocated to HIIT groups
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo (EEFERP USP)
Ribeirão Preto, São Paulo
Ellen C de Freitas, PhD, +55163315-0345, ellenfreitas@usp.br
About this study
Official title: Effects of Taurine Supplementation Combined With Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity
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:
- Is the modulation of circadian clock gene expression associated with the anti-inflammatory effects of taurine?
- Does the timing of HIIT (morning or evening) affect circadian clock gene expression and inflammatory and metabolic responses? Researchers will compare six groups to evaluate the effects of taurine supplementation, HIIT performed in the morning or evening, and their combination.
Read more
Participants will:
- Take taurine (3g/day) or a matching placebo for 12 weeks, according to their assigned group;
- Perform HIIT in the morning or evening if assigned to an exercise group;
- Attend study visits at baseline (week 0) and after 12 weeks for assessments of metabolic and inflammatory parameters, circadian clock gene expression in peripheral blood mononuclear cells (PBMCs), as well as anthropometric measures, body composition and cardiorrespiratory fitness.
- Conditions
- Obesity (Disorder), Inflammation
- Being tested
- Taurine supplementation, Placebo Supplementation, High-intensity interval training (HIIT)
- Keywords
- Obesity, Inflammation, Circadian rhythms, Taurine, HIIT
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurine supplementationDietary supplement
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.
Placebo SupplementationDrug
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.
High-intensity interval training (HIIT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control (CONT) | No intervention | Participants will not receive supplementation or participate in the exercise training program. |
| Taurine (TAU) | Experimental | Participants will receive taurine supplementation without participating in the exercise training program. Receives: Dietary Supplement: Taurine supplementation |
| Taurine + Morning Exercise (TAU + MEx) | Experimental | Participants will receive taurine supplementation and perform high-intensity interval training (HIIT) in the morning Receives: Dietary Supplement: Taurine supplementation; Behavioral: High-intensity interval training (HIIT) |
| Taurine + Evening Exercise (TAU + EEx) | Experimental | Participants will receive taurine supplementation and perform HIIT in the evening. Receives: Dietary Supplement: Taurine supplementation; Behavioral: High-intensity interval training (HIIT) |
| Placebo + Morning Exercise (PLA + MEx) | Placebo comparator | Participants will receive placebo capsules identical in appearance to the taurine capsules and perform HIIT in the morning. Receives: Drug: Placebo Supplementation; Behavioral: High-intensity interval training (HIIT) |
| Placebo + Evening Exercise (PLA + EEx) | Placebo comparator | Participants will receive placebo capsules identical in appearance to the taurine capsules and perform HIIT in the evening. Receives: Drug: Placebo Supplementation; Behavioral: High-intensity interval training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and post-intervention (Week 12).
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and post-intervention (Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This 12-week randomized, controlled, double-blind clinical trial will follow the CONSORT guidelines. Participants will be randomly allocated using computer-generated sequences, with allocation concealment ensured by an independent researcher. Six groups will be included: taurine + morning HIIT (TAU + MEx), taurine + evening HIIT (TAU + EEx), placebo + morning HIIT (PLA + MEx), placebo + evening HIIT (PLA + EEx), taurine without exercise (TAU), and control without supplementation or exercise (CONT). Placebo capsules will be identical in appearance to taurine capsules. Participants and the principal investigator will be blinded to group allocation, as applicable. After recruitment and eligibility screening, assessments will be conducted at baseline (week 0) and repeated after the 12-week intervention (week 12) to evaluate changes in all prespecified outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910747
- Sponsor's protocol ID
- TAUHIITCLOCK-OBESITY-001
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taurine Supplementation Combined With Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity
- ClinicalTrials.gov ID
- NCT07910747
- Acronym / sponsor ID
- TAUHIITCLOCK-OBESITY-001
- Conditions
- Obesity (Disorder), Inflammation
- Keywords
- Obesity, Inflammation, Circadian rhythms, Taurine, HIIT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the modulation of circadian clock gene expression associated with the anti-inflammatory effects of taurine?
- Does the timing of HIIT (morning or evening) affect circadian clock gene expression and inflammatory and metabolic responses? Researchers will compare six groups to evaluate the effects of taurine supplementation, HIIT performed in the morning or evening, and their combination.
Participants will:
- Take taurine (3g/day) or a matching placebo for 12 weeks, according to their assigned group;
- Perform HIIT in the morning or evening if assigned to an exercise group;
- Attend study visits at baseline (week 0) and after 12 weeks for assessments of metabolic and inflammatory parameters, circadian clock gene expression in peripheral blood mononuclear cells (PBMCs), as well as anthropometric measures, body composition and cardiorrespiratory fitness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- This 12-week randomized, controlled, double-blind clinical trial will follow the CONSORT guidelines. Participants will be randomly allocated using computer-generated sequences, with allocation concealment ensured by an independent researcher. Six groups will be included: taurine + morning HIIT (TAU + MEx), taurine + evening HIIT (TAU + EEx), placebo + morning HIIT (PLA + MEx), placebo + evening HIIT (PLA + EEx), taurine without exercise (TAU), and control without supplementation or exercise (CONT). Placebo capsules will be identical in appearance to taurine capsules. Participants and the principal investigator will be blinded to group allocation, as applicable. After recruitment and eligibility screening, assessments will be conducted at baseline (week 0) and repeated after the 12-week intervention (week 12) to evaluate changes in all prespecified outcomes.
| Arm | Type | Receives |
|---|---|---|
| Control (CONT) | No intervention | –Participants will not receive supplementation or participate in the exercise training program. |
| Taurine (TAU) | Experimental | Dietary Supplement: Taurine supplementationParticipants will receive taurine supplementation without participating in the exercise training program. |
| Taurine + Morning Exercise (TAU + MEx) | Experimental | Dietary Supplement: Taurine supplementation, Behavioral: High-intensity interval training (HIIT)Participants will receive taurine supplementation and perform high-intensity interval training (HIIT) in the morning |
| Taurine + Evening Exercise (TAU + EEx) | Experimental | Dietary Supplement: Taurine supplementation, Behavioral: High-intensity interval training (HIIT)Participants will receive taurine supplementation and perform HIIT in the evening. |
| Placebo + Morning Exercise (PLA + MEx) | Placebo comparator | 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 morning. |
| Placebo + Evening Exercise (PLA + EEx) | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have a body mass index (BMI) of 30-39.9 kg/m² (class I or II obesity) for at least 3 years and a body fat percentage ≥35%;
- Have maintained stable body weight during the 3 months preceding the study;
- Have a predominantly nocturnal sleep schedule and no history of night-shift or rotating-shift work during the previous 6 months;
- Have not participated in structured exercise training programs or undertaken restrictive diets or other nutritional interventions during the 3 months preceding the study;
- Have serum high-sensitivity C-reactive protein (hs-CRP) levels >1 and <10 mg/L, consistent with low-grade systemic inflammation, in the absence of clinical or laboratory evidence of infection or an acute inflammatory process.
Key exclusion criteria (8 listed)
- Have hs-CRP levels ≥10 mg/L;
- Present signs or symptoms suggestive of infection or an acute inflammatory process, including fever, flu-like symptoms, recent infections, use of antibiotics or anti-inflammatory medications, or recent vaccination;
- Have a diagnosed chronic inflammatory disease or have experienced an acute infectious process within the 2 weeks preceding the assessments;
- Have insulin-dependent diabetes mellitus, established cardiovascular disease, uncontrolled hypertension, or clinically significant sleep disorders;
- Regularly use medications such as immunosuppressants, glucose-lowering agents, corticosteroids, or anti-inflammatory drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurine supplementationTaurine 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. | Dietary supplement | Taurine (TAU), Taurine + Evening Exercise (TAU + EEx), Taurine + Morning Exercise (TAU + MEx) |
| Placebo SupplementationMatching 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. | Drug | Placebo + Evening Exercise (PLA + EEx), Placebo + Morning Exercise (PLA + MEx) |
| High-intensity interval training (HIIT)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. | Behavioural | Placebo + Evening Exercise (PLA + EEx), Placebo + Morning Exercise (PLA + MEx), Taurine + Evening Exercise (TAU + EEx), Taurine + Morning Exercise (TAU + MEx) |
Primary outcome
Changes in diurnal variation of BMAL1 gene expression in peripheral blood mononuclear cells (PBMCs)
Time frame: 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.
22 secondary outcomes
Changes in diurnal variation of CLOCK gene expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of PER genes expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of CRY genes expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in diurnal variation of NR1D1 gene expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in BMAL1 protein expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in CLOCK protein expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in PER proteins expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in CRY proteins expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in NR1D1 protein expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in serum cytokines concentrations
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
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
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in glycemic profile, including fasting blood glucose, fasting insulin and insulin resistance
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in lipidic profile, including total cholesterol, HDL and LDL cholesterol and triglycerides
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in body weight and body mass index (BMI)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in waist and hip circumferences
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in body composition parameters
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in peak oxygen uptake (VO₂peak)
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in maximal heart rate
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in plasma taurine concentrations
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in dietary intake
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Changes in Peripheral Blood Mononuclear Cell (PBMC) Subpopulations
Time frame: Baseline (Week 0) and post-intervention (Week 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurine supplementation and High-intensity interval training (HIIT) in people with Obesity (Disorder) and Inflammation, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen C de Freitas, PhD (+55163315-0345, ellenfreitas@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in diurnal variation of BMAL1 gene expression in peripheral blood mononuclear cells (PBMCs) (time frame: Baseline (Week 0) and post-intervention (Week 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.