Dietary Fructose on Microbiota and Hepatosteatosis

Not Applicable

Completed

• Conditions: Dietary Fructose Exposure; Hepatic Steatosis
• Interventions: Dietary Supplement: 75g fructose solution; Dietary Supplement: 150g fructose solution

• Registration Number: NCT04898621
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-24
• Study Start: 2021-06-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

1. Healthy men aged from 18 to 40 (including both ends);
2. Body mass index (BMI) ranges from 18.5 to 23.9 kg/m2 (including both ends);
3. The body weight has not changed dramatically in the past 3 months (±3kg);

Exclusion Criteria

1. Subjects who have received antibiotic-related treatment, proton pump inhibitor treatment, or glucocorticoid hormone treatment within 1 month before enrollment;
2. Subjects with diabetes or cardiovascular disease or other chronic diseases who require long-term medication;
3. Subjects who suffered from an acute gastrointestinal diseases within the past month, or who have an history of chronic gastrointestinal disease or hepatitis;
4. Subjects with a history of gastrointestinal surgery;
5. Subjects with abnormal liver or kidney function, or severe cardiovascular diseases;
6. Subjects with mental disorders or impaired cognitive function;
7. Poor compliance;
8. Participates enrolled in other clinical research at the same time;
9. Other unsuitable occasions judged by clinicians..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	75g fructose solution	Subjects in Group A will drink 75g fructose solution daily for 4 weeks.
Group B	150g fructose solution	Subjects in Group B will drink 150g fructose solution daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change of intra-hepatic triglyceride content(IHTG)	4 weeks	The IHTG will be measured using MRI-PDFF
Change of microbiota	4 weeks	The change of microbiota in fecal samples from baseline to the end of the study

Secondary Outcome Measures

Name	Time	Method
The change of serum proinflammatory factors	4 weeks	Serum proinflammatory factors, including TNFa, IL-6 will be measured.
Change of serum metabolomics	4 weeks	Serum metabolomics will be determined using MS.

Trial Locations

Locations (1)

Department of Endocrinology, Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China