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Completed

NCT Number: NCT04898621

Dietary Fructose on Microbiota and Hepatosteatosis

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Zhongshan Hospital Fudan University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

75g fructose solution

Dietary Supplement

Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.

150g fructose solution

Dietary Supplement

Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.

Primary outcomes

  1. Change of microbiota

    Time frame: 4 weeks

    The change of microbiota in fecal samples from baseline to the end of the study

  2. Change of intra-hepatic triglyceride content(IHTG)

    Time frame: 4 weeks

    The IHTG will be measured using MRI-PDFF

Secondary outcomes

  1. Change of serum metabolomics

    Time frame: 4 weeks

    Serum metabolomics will be determined using MS.

  2. The change of serum proinflammatory factors

    Time frame: 4 weeks

    Serum proinflammatory factors, including TNFa, IL-6 will be measured.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Fudan University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2021
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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