NCT04898621

Dietary Fructose on Microbiota and Hepatosteatosis

The Effect of Dietary Fructose on Gut Microbiota and Hepatosteatosis in Healthy Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatic Steatosis
• Dietary Fructose Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	75g fructose solution	Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.
DIETARY_SUPPLEMENT	150g fructose solution	Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-08-31
• Completion: 2022-12-31
• First posted: 2021-05-24
• Last updated: 2023-06-07

Locations

1 site across 1 country: China