Background
Obesity is a major public health problem in recent decades. The accumulation of excessive fat promotes inflammatory status. Meanwhile, herbal products are marketed for their weight-loss properties, such as
Nigella sativa
(
N. Sativa
) which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of
N. sativa
have also been indicated. However, the exact mechanisms and cellular-related pathways are still unclear. Thus, we will aim to assess the effects of oral
N. sativa
on the gene expression of inflammatory and adipogenesis-related factors, including TNF-α, PPAR-γ, and adiponectin as well as assessing their serum concentrations among obese and overweight individuals.
Methods
Obese and overweight women aged 25–55 years with a body mass index (BMI) of 25–35 kg/m
2
will be recruited from the Obesity Clinic in Shahid Sadoughi University of Medical Sciences and will be assessed for eligibility against inclusion criteria. They will be randomly assigned into two groups to receive either two capsules of
N. sativa
or two capsules of placebo per day for eight weeks (each capsule contains 1000 mg of
N. sativa
or placebo). There will be a four-week wash-out period and then participants will receive the reverse supplements for another eight weeks. Biochemical assessments and gene expressions (using real-time polymerase chain reaction) will be conducted at the beginning and at the end of every intervention period.
Discussion
The present study will investigate the probable cellular pathways for the anti-obesity effects of
N. sativa
in overweight/obese women.
Trial registration
Iranian Registry of Clinical Trials,
IRCT20180528039884N1
. Registered on 2nd of July, 2018.
Electronic supplementary material
The online version of this article (10.1186/s13063-019-3568-0) contains supplementary material, which is available to authorized users.
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