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The effect of Nigella sativa supplementation on cardiovascular risk factors in obese and overweight women: a crossover, double-blind, placebo-controlled randomized clinical trial

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European Journal of Nutrition Aims and scope Submit manuscript

Abstract

Purpose

To assess the effect of Nigella sativa (N.S) oil supplements on CVD risk factors in a crossover design for the first time.

Methods

Obese and overweight healthy women were randomized to receive N.S oil (2000 mg/day) and placebo. This intervention period lasted for 8 weeks and separated by a 4-week washout period. An iso-caloric diet was given to every individual throughout the study. Blood pressure, lipid profile, atherogenic indices and liver enzymes were measured. Pkcross procedure was performed for statistical analyses using Stata software. Cohen’s d was estimated as effect size for all outcomes to measure the magnitude of the effects.

Results

Thirty-nine participants completed the study. Capsules of N.S increased serum high-density lipoprotein cholesterol (Cohen’s d = 0.47, P = 0.009), reduced low-density lipoprotein cholesterol (Cohen’s d = − 0.33, P = 0.031), reduced TC/HDL-C ratio (as an atherogenic index, Cohen’s d = − 0.9, P < 0.001), reduced serum glutamic-oxaloacetic transaminase (Cohen’s d = 0− 0.5, P = 0.038) and reduced systolic blood pressure (Cohen’s d = − 0.4, P < 0.001). There was no effect on diastolic blood pressure measures (P = 0.96).

Conclusion

The overall improvements in cardiovascular disease (CVD) risk factors showed beneficial effects of N.S supplements among adults with obesity to prevent possible cardiovascular diseases. More studies with different designs and in other populations are suggested to clarify the exact effects of N.S as a complementary therapy for modulating CVD risk factors in individuals with overweight and obesity.

Trial registration

Iranian Registry of Clinical Trials, IRCT20180528039884N1, Registered on February 15th, 2019.

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Data availability

The datasets generated during the current study are available via the corresponding author on reasonable request.

Code availability

Not applicable.

Notes

  1. Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial (Published on August 17th, 2019).

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Acknowledgements

We would like to express our gratitude to all the participants and members who participated in this study as well as the obesity clinic at Shahid Sadoughi University of Medical Sciences, and Barij Essence Pharmaceutical Co. for their executive supports. We would also like to thank Shahid Sadoughi University of Medical Sciences and Iran’s National Science Foundation (INSF) for their financial and executive supports.

Funding

This study is funded by Shahid Sadoughi University of Medical Sciences (No. 961020). Moreover, Iran’s National Science Foundation (INSF) has provided an educational grant funding for this trial (No. 96012986).

Author information

Authors and Affiliations

  1. Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Elham Razmpoosh, Sara Safi, Azadeh Nadjarzadeh, Nooshin Abdollahi & Amin Salehi-Abargouei

  2. Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Elham Razmpoosh, Sara Safi, Azadeh Nadjarzadeh, Nooshin Abdollahi & Amin Salehi-Abargouei

  3. Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Elham Razmpoosh

  4. Research Center of Prevention and Epidemiology of Non Communicable Disease, Department of Biostatistics and Epidemiology, Health Faculty, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Hossien Fallahzadeh

  5. Department of Medical Genetics, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Mahta Mazaheri

  6. Mother and Newborn, Health Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Mahta Mazaheri

  7. Department of Medical Genetics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Majid Nazari

Authors
  1. Elham Razmpoosh
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  2. Sara Safi
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  3. Azadeh Nadjarzadeh
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  4. Hossien Fallahzadeh
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  6. Mahta Mazaheri
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  8. Amin Salehi-Abargouei
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Contributions

All authors contributed to the idea and design of the study. ER and SF performed the idea of this study, study design, and were major contributors to the writing and reviewing of the manuscript. AN and MM reviewed and contributed to the manuscript. ER, SF, NA and MN participated in the design, participant recruitment and performing laboratory tests. HF and ASA provided statistical expertise in clinical trial design and reviewed and contributed to the manuscript. ASA and ER edited the final version of the manuscript.

Corresponding author

Correspondence to Amin Salehi-Abargouei.

Ethics declarations

Competing interest

The authors declare that they have no conflict of interest.

Ethical approval

The protocol of the present study was approved by the ethics committee of Shahid Sadoughi University of Medical Sciences on December 15th, 2018 (IR.SSU.SPH.REC.1397.007). A previously published protocol article with detailed design, ethics approval and details of participation is also available for this study Footnote 1.

Consent to participate

All the participants were asked to sign an informed consent form after providing them related information about the procedure of the study. Participant recruitment was started on April 21st, 2019.

Consent for publication

Not applicable.

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Razmpoosh, E., Safi, S., Nadjarzadeh, A. et al. The effect of Nigella sativa supplementation on cardiovascular risk factors in obese and overweight women: a crossover, double-blind, placebo-controlled randomized clinical trial. Eur J Nutr 60, 1863–1874 (2021). https://doi.org/10.1007/s00394-020-02374-2

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  • DOI: https://doi.org/10.1007/s00394-020-02374-2

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