Dietary Fructose on Microbiota and Hepatosteatosis

June 5, 2023 updated by: Xiaoying Li, Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Department of Endocrinology, Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Subjects in Group A will drink 75g fructose solution daily for 4 weeks.
Dietary supplement: 75g fructose solution
Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.
Experimental: Group B
Subjects in Group B will drink 150g fructose solution daily 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum metabolomics
Time Frame: 4 weeks
Serum metabolomics will be determined using MS.
4 weeks
The change of serum proinflammatory factors
Time Frame: 4 weeks
Serum proinflammatory factors, including TNFa, IL-6 will be measured.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Fudan University

Investigators

  • Principal Investigator: Xiaoying Li, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSE202105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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