Department of Endocrinology, Zhongshan Hospital Fudan University
Shanghai, China
NCT Number: NCT04898621
The consumption of sugar-sweetened beverages (SSB) has increased steadily over the past decades, resulting in the dramatic increase of fructose intake as it is one of the main ingredients of artificial sweeteners. Recently, large epidemiological studies have documented the association between a high-fructose-diet and hepatic steatosis, and other metabolic disorders. So it is interesting for scientists to explore the underlying mechanism. This study aims to investigate the effect of dietary fructose and gut microbiota and the hepatosteatosis in healthy men. Serum and fecal metabolomics will be investigated.
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Notify Me18 year–40 year
Male
Interventional
Not applicable
Shanghai, China
This is a single center, randomized, controlled study. 60 healthy men will be recruited according to the inclusion criteria. All subjects are randomly allocated to Group A and Group B, who orally takes 75g and 150g fructose daily respectively. Subjects in Group A will be instructed to drink fructose solution containing 75g fructose per day, and those in Group B will be instructed to drink fructose solution containing 150g fructose per day. The intervention will last four weeks. The anthropomentric data will be collect with questionnaire and serum and fecal samples collected at baseline and the end of the intervention. The effect and mutual interaction of dietary fructose and microbiota will be explored. The effect of dietary fructose on hepatosteatosis will be investigated as well.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.
Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.
Time frame: 4 weeks
The change of microbiota in fecal samples from baseline to the end of the study
Time frame: 4 weeks
The IHTG will be measured using MRI-PDFF
Time frame: 4 weeks
Serum metabolomics will be determined using MS.
Time frame: 4 weeks
Serum proinflammatory factors, including TNFa, IL-6 will be measured.
Shanghai Zhongshan Hospital
Other
The Effect of Dietary Fructose on Gut Microbiota and Hepatosteatosis in Healthy Men
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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