Abstract
BackgroundThe prevalence of central obesity is constantly increasing, and visceral fat is associated with increased production of inflammatory factors and metabolic risk factors. Lutein might retard the development of metabolic disease through its antioxidant and anti-inflammatory properties. Furthermore, epidemiological studies have associated higher dietary intake and serum levels of lutein with decreased adiposity. However, few randomised controlled trials have shown the effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors, especially in adults with central obesity.MethodsThis study will be conducted as a double-blind, parallel placebo-controlled clinical trial in which 120 people who have central obesity, are 18 to 60 years old and are willing to provide informed consent will be randomly assigned to the intervention or placebo group in a 1:1 ratio according to sex, age and waist circumference. The intervention group will receive 10 mg daily lutein supplementation for 12 weeks to explore the effect of lutein supplementation on serum lutein, glycaemic and lipid profiles, inflammatory factors and body composition. Two populations (intention-to-treat population and per-protocol population) will be used in the data analyses.DiscussionOur findings from this trial will contribute to the knowledge of the association between lutein supplementation and inflammatory biomarkers and metabolic risk factors in people with central obesity and will offer a possibility for the prevention of inflammatory diseases.Trial registrationChinese Clinical Trial Registry: ChiCTR1800018098. Registered on 30 August 2018.
Highlights
The prevalence of obesity has constantly increased and has reached epidemic proportions
Epidemiological studies have indicated that visceral fat is correlated with insulin resistance (IR) and glucose intolerance and increasing levels of C-reactive protein (CRP), Tumour necrosis factor-alpha (TNF-α), IL-6, isoprostanes and monocyte chemoattractant protein-1 (MCP-1) [13, 14]
The proposed clinical trial will be conducted at the Community Health Service Centre (CHSC) in Nanshan District, Shenzhen, Guangzhou Province, China, for 12 weeks to assess the effects of lutein supplementation (10 mg/d) on inflammatory biomarkers and metabolic risk factors in adults with central obesity
Summary
The prevalence of obesity has constantly increased and has reached epidemic proportions. It is clear that the levels of oxidative stress and inflammatory factors increase as the amount of adipose tissue increases. The adipokines—interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-α), adiponectin, leptin and resistin—secreted by adipose tissue play a role in the homeostasis of various physiological processes, such as insulin sensitivity, energy expenditure and fatty acid oxidation [8, 9]. The prevalence of central obesity is constantly increasing, and visceral fat is associated with increased production of inflammatory factors and metabolic risk factors. Epidemiological studies have associated higher dietary intake and serum levels of lutein with decreased adiposity. Few randomised controlled trials have shown the effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors, especially in adults with central obesity
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