Anti-hyperlipidemic effects of 500 mg spilanthol (SA3X) supplementation in people with dyslipidemia – a randomized, parallel-group placebo-controlled trial
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Kumar Guru Mishra
,
Nabnita Patnaik
and
Nihar Ranjan Pradhan
Abstract
Objectives
Dyslipidemia is a critical risk factor for cardiovascular disease. This study investigated the impact of 500 mg of spilanthol (SA3X) supplementation on lipid profiles in men with dyslipidemia using a randomized, parallel-group, placebo-controlled design.
Methods
A total of 279 male participants were randomly allocated to one of four groups: SA3X without exercise, placebo without exercise, SA3X with exercise, and placebo with exercise. After a one-month control period, participants received SA3X capsules or placebo for three months. The exercise groups undertook standardized weight-lifting exercises four times weekly. Lipid profiles, biochemical parameters, and anthropometric measurements were monitored throughout and after the intervention.
Results
Both SA3X groups exhibited significant reductions in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) compared to the placebo groups. By day 90, the SA3X-no-exercise group showed a 16.78 % decrease in TC, while the SA3X-plus-exercise group demonstrated a 52.87 % decrease compared to placebo. Significant reductions in TG and LDL-C were noted at days 60 and 90 (p=0.01 and p=0.03, respectively). The SA3X-plus-exercise group also exhibited decreased random blood sugar levels at days 60 and 90 compared to placebo-plus-exercise. Moreover, decreases in C-reactive protein, creatine kinase, and serum creatinine levels were observed.
Conclusions
SA3X supplementation, particularly when combined with exercise, effectively improved lipid profiles and various health markers in men with dyslipidemia. Adverse events, primarily taste disturbance, were mild. These findings suggest SA3X may be a promising adjunctive therapy for managing dyslipidemia, emphasizing its potential cardiovascular health benefits and supporting further investigation.
Trial registration
CTRI/2021/05/033694; May 2021.
Acknowledgments
The authors express their gratitude to the participants and Stiriti Ayur Therapies Pvt Ltd, the manufacturer of SA3X, for the provision of the capsules used in the study.
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Research ethics: Ethical clearance was obtained from the Institutional Ethics Committee of Apollo Hospitals, Hyderabad (AHJ-C-S-008/12-21) and the study was conducted in accordance with the Declaration of Helsinki.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Author contributions: KGM and NP conceptualised the study design. KGM, NP and NRP conducted data collection and analysis. KGM drafted the initial manuscript. NP and NRP contributed to the revision of the manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: The raw data can be obtained on considerable request from the corresponding author.
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Articles in the same Issue
- Frontmatter
- Reviews
- Boldine: a narrative review of the bioactive compound with versatile biological and pharmacological potential
- Potential anti-cancer activity of Moringa oleifera derived bio-active compounds targeting hypoxia-inducible factor-1 alpha in breast cancer
- Research Articles
- Phytochemical characterisation and toxicity effect of Tithonia diversifolia (Hemls.) A. Gray leaf extract on fall army worm Spodoptera frugiperda (JE Smith) larvae
- Management of wounds in diabetes by administering allicin and quercetin in emulsion form as wound medicine in diabetic rat models
- Evaluation of anti-nociceptive and anti-inflammatory activities of solvent fraction of the roots of Echinops kebericho Mesfin (Asteraceae) in mice model
- A spectrometric analysis of variedly purified cinnabar in a siddha drug – linga chendhooram
- Palm oil amends serum female hormones, ovarian antioxidants, inflammatory markers, and DNA fragmentation in favism-induced female rats
- Brazil nuts potential: effects on lipid peroxidation and heart health in nephrectomized rats
- Preclinical antidiabetic and antioxidant effects of Erythrophleum africanum (benth.) harms in streptozotocin-induced diabetic nephropathy
- Pharmacognostical characterization, GC-MS profiling, and elemental analysis of Curcuma caesia Roxb. rhizomes for public health
- Antibacterial activity of Macrosciadium alatum (M.Bieb.) plant extract
- Effect of horticultural therapy on static, dynamic balance and gait speed among institutionalized older adults with cognitive impairment
- Anti-hyperlipidemic effects of 500 mg spilanthol (SA3X) supplementation in people with dyslipidemia – a randomized, parallel-group placebo-controlled trial
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