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Study protocol
Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomized controlled study
Xiaolin Peng
Shenzhen Nanshan Centre for Chronic Disease Control
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: The prevalence of central obesity is increasing consistently, 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 randomized controlled trials (RCTs) have shown the effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors, especially in adults with central obesity.
Methods: This study will be conducted as a double-blinded, parallel placebo-controlled clinical trial in which 120 people with central obesity aged 18-60 years old and 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.
Discussion: Our 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, which will offer a possibility for the prevention of inflammatory diseases.
Keywords
Lutein supplementation, central obesity, inflammatory biomarkers, metabolic risk factors
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CURRENT STATUS: Published
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Posted 19 Dec, 2019
Published
On 06 Jan, 2020
No community comments so far
Editorial decision: Accept
On 14 Dec, 2019
Editor assigned
On 13 Dec, 2019
Submission checks complete
On 12 Dec, 2019
No comments provided
Editor assigned
On 10 Dec, 2019
Submission checks complete
On 09 Dec, 2019
Editorial decision: Minor revision
On 09 Dec, 2019
No comments provided
Reviewers invited
Invitations sent on 13 Nov, 2019
Reviewer #1 agreed
On 13 Nov, 2019
Review #1 received
Received 13 Nov, 2019
Editorial decision: Major revision
On 13 Nov, 2019
Editor assigned
On 12 Nov, 2019
Submission checks complete
On 12 Aug, 2019
First submitted
On 11 Aug, 2019
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomized controlled study
Xiaolin Peng
Shenzhen Nanshan Centre for Chronic Disease Control
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 19 Dec, 2019
Published
On 06 Jan, 2020
No community comments so far
Editorial decision: Accept
On 14 Dec, 2019
Editor assigned
On 13 Dec, 2019
Submission checks complete
On 12 Dec, 2019
No comments provided
Editor assigned
On 10 Dec, 2019
Submission checks complete
On 09 Dec, 2019
Editorial decision: Minor revision
On 09 Dec, 2019
No comments provided
Reviewers invited
Invitations sent on 13 Nov, 2019
Reviewer #1 agreed
On 13 Nov, 2019
Review #1 received
Received 13 Nov, 2019
Editorial decision: Major revision
On 13 Nov, 2019
Editor assigned
On 12 Nov, 2019
Submission checks complete
On 12 Aug, 2019
First submitted
On 11 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: The prevalence of central obesity is increasing consistently, 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 randomized controlled trials (RCTs) have shown the effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors, especially in adults with central obesity.
Methods: This study will be conducted as a double-blinded, parallel placebo-controlled clinical trial in which 120 people with central obesity aged 18-60 years old and 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.
Discussion: Our 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, which will offer a possibility for the prevention of inflammatory diseases.
Figure 1