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Effects of Taurine Supplementation and Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity

NCT07910747 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2027-01
Last updated
2026-11-02

Condition(s) studied

Obesity (Disorder)Inflammation

Investigational drug(s) / intervention(s)

Taurine supplementationPlacebo SupplementationHigh-intensity interval training (HIIT)

Taurine supplementation: 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 Supplementation: 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): 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 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. 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria 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. Exclusion Criteria 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

Primary outcome measure(s)

  • Changes 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.

Trial sites (1)

FacilityCityRegionStatus
School of Physical Education and Sport of Ribeirao Preto, University of Sao Paulo (EEFERP USP) Ribeirão Preto São Paulo
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07910747 on ClinicalTrials.gov ↗ ← All trials in Brazil