Dietary Fructose on Microbiota and Hepatosteatosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatic Steatosis, Dietary Fructose Exposure

Intervention / Treatment
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* Dietary Supplement: 75g fructose solution
* Dietary Supplement: 150g fructose solution


Participation Criteria
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Eligibility Criteria
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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..

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects in Group A will drink 75g fructose solution daily for 4 weeks. | Dietary Supplement: 75g fructose solution<br>* Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.<br>|
| Experimental: Group B<br>Subjects in Group B will drink 150g fructose solution daily for 4 weeks. | Dietary Supplement: 150g fructose solution<br>* Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, Fructose, Microbiota