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Dietary Fructose on Microbiota and Hepatosteatosis

Primary Purpose

Hepatic Steatosis, Dietary Fructose Exposure

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
75g fructose solution
150g fructose solution
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatic Steatosis focused on measuring Fructose, Microbiota, NAFLD

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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..

Sites / Locations

  • Department of Endocrinology, Zhongshan Hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Subjects in Group A will drink 75g fructose solution daily for 4 weeks.

Subjects in Group B will drink 150g fructose solution daily for 4 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2021
Last Updated
June 5, 2023
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04898621
Brief Title
Dietary Fructose on Microbiota and Hepatosteatosis
Official Title
The Effect of Dietary Fructose on Gut Microbiota and Hepatosteatosis in Healthy Men
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Steatosis, Dietary Fructose Exposure
Keywords
Fructose, Microbiota, NAFLD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
60 healthy men will be recruited according to the inclusion criteria. All the participates are randomly allocated to Group A and Group B. 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 150g fructose per day.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects in Group A will drink 75g fructose solution daily for 4 weeks.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Subjects in Group B will drink 150g fructose solution daily for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
75g fructose solution
Intervention Description
Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
150g fructose solution
Intervention Description
Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.
Primary Outcome Measure Information:
Title
Change of microbiota
Description
The change of microbiota in fecal samples from baseline to the end of the study
Time Frame
4 weeks
Title
Change of intra-hepatic triglyceride content(IHTG)
Description
The IHTG will be measured using MRI-PDFF
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change of serum metabolomics
Description
Serum metabolomics will be determined using MS.
Time Frame
4 weeks
Title
The change of serum proinflammatory factors
Description
Serum proinflammatory factors, including TNFa, IL-6 will be measured.
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men aged from 18 to 40 (including both ends); Body mass index (BMI) ranges from 18.5 to 23.9 kg/m2 (including both ends); The body weight has not changed dramatically in the past 3 months (±3kg); Exclusion Criteria: Subjects who have received antibiotic-related treatment, proton pump inhibitor treatment, or glucocorticoid hormone treatment within 1 month before enrollment; Subjects with diabetes or cardiovascular disease or other chronic diseases who require long-term medication; Subjects who suffered from an acute gastrointestinal diseases within the past month, or who have an history of chronic gastrointestinal disease or hepatitis; Subjects with a history of gastrointestinal surgery; Subjects with abnormal liver or kidney function, or severe cardiovascular diseases; Subjects with mental disorders or impaired cognitive function; Poor compliance; Participates enrolled in other clinical research at the same time; Other unsuitable occasions judged by clinicians..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Zhongshan Hospital Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Dietary Fructose on Microbiota and Hepatosteatosis

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