Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Feb 16;9(1):32.
doi: 10.1186/s40795-023-00690-4.

The effects of royal jelly supplementation on oxidative stress, inflammatory mediators, mental health, cognitive function, quality of life, and clinical outcomes of patients with ischemic stroke: study protocol for a randomized controlled trial

Elham Karimi  1   2 , Fariborz Khorvash  3 , Arman Arab  4 , Mahdi Sepidarkish  5 , Mohammad Saadatnia  3 , Reza Amani  6
Affiliations

The effects of royal jelly supplementation on oxidative stress, inflammatory mediators, mental health, cognitive function, quality of life, and clinical outcomes of patients with ischemic stroke: study protocol for a randomized controlled trial

Elham Karimi et al. BMC Nutr. .

Abstract

Background: Stroke is a debilitating disease that affects over 15 million people worldwide each year, resulting in the death of one-third of those people and severe disability in two-thirds of survivors. Previous studies reported various health benefits of Royal jelly in the context of its anti-inflammatory properties. We will aim to investigate the effects of royal jelly supplementation on oxidative stress, inflammatory mediators, mental health, cognitive function, quality of life, and clinical outcomes of patients with ischemic stroke.

Methods: The present study will be a triple-blind randomized placebo trial. Patients who meet our eligibility criteria will be assigned to the intervention or the control groups to receive allocated intervention for 12 weeks. Individuals of the intervention group will consume 1000 mg of Royal jelly dragee daily after breakfast. Subjects of the control group will receive a placebo dragee identical to the Royal jelly dragee. The severity of the stroke, cognitive function, mental health, quality of life, clinical outcomes, and biochemical measures will be assessed at baseline and post-intervention.

Discussion: The current study is designed to investigate the effectiveness and safety of royal jelly supplementation in a randomized, parallel, two-arms, single-center, triple-blind, placebo-controlled manner. This study will provide evidence as a phase III clinical trial.

Trial registration: IRCT20180818040827N4, registered on 16 October 2021. https://www.irct.ir/trial/59275.

Keywords: Inflammation; Integrative medicine; Ischemic stroke; Quality of life; Royal jelly.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Diagram of the study process
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2016;47(6):e98–e169. doi: 10.1161/STR.0000000000000098. - DOI - PubMed
    1. Wafa HA, Wolfe CD, Bhalla A, Wang Y. Long-term trends in death and dependence after ischaemic strokes: a retrospective cohort study using the South London stroke register (SLSR) PLoS Med. 2020;17(3):e1003048. doi: 10.1371/journal.pmed.1003048. - DOI - PMC - PubMed
    1. Shi K, Tian D-C, Li Z-G, Ducruet AF, Lawton MT, Shi F-D. Global brain inflammation in stroke. Lancet Neurol. 2019;18(11):1058–1066. doi: 10.1016/S1474-4422(19)30078-X. - DOI - PubMed
    1. Lambertsen KL, Finsen B, Clausen BH. Post-stroke inflammation—target or tool for therapy? Acta Neuropathol. 2019;137(5):693–714. doi: 10.1007/s00401-018-1930-z. - DOI - PMC - PubMed
    1. Niizuma K, Yoshioka H, Chen H, Kim GS, Jung JE, Katsu M, et al. Mitochondrial and apoptotic neuronal death signaling pathways in cerebral ischemia. Biochimica et Biophysica Acta (BBA)-Mol Basis Dis. 2010;1802(1):92–99. doi: 10.1016/j.bbadis.2009.09.002. - DOI - PMC - PubMed

LinkOut - more resources