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NCT05558592Completed

Evaluation of the Effects of Orange Consumption on Carbohydrate and Lipid Metabolism in Subjects With MAFLD (Metabolic Associated Fatty Liver Disease)

Source: ClinicalTrials.gov · Last updated 25 Mar 2026

Brief summary (registry, in English)

Given the current increase in the incidence of dyslipidemia and obesity in the general population, there is a strong interest in identifying dietary factors capable of preventing the onset of metabolic diseases or at least capable of reducing metabolic risk. Several experimental evidences have shown that improving the carbohydrate and lipid profile in subjects at risk can reduce mortality linked to cardiovascular, neurodegenerative diseases and cancer. The diet is, therefore, an effective prevention tool in combating diseases related to metabolism, such as MAFLD (Metabolic Associated Fatty Liver Disease). In particular, fruit with its high content of polyphenols has been shown to exert a high anti-inflammatory, antithrombotic and antiproliferative action. Polyphenols extracted from oranges of the "Tacle" variety have demonstrated in vitro an inhibitory action of cholesterol synthesis. In addition, the consumption of orange juice has been shown to improve the serum lipid profile of obese subjects, as well as "hesperedine", a flavonoid mainly present in oranges is able to reduce the proliferative activity of MCF-7 (human breast cancer cell line with estrogen, progesterone and glucocorticoid receptors) cells.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
21 Sept 2022
Start date
1 Mar 2023
Primary completion date
30 Jul 2023
Lead sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
NCT number
NCT05558592

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 1 Mar 2023 to the primary completion date, 30 Jul 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • gastroesophageal reflux diseases;
  • inflammatory bowel diseases; oncological diseases;
  • serious medical conditions that may impair participation in the trial;

Other

  • people who follow a special diet or who use anticoagulants;
  • subjects unable to follow a diet for religious or other reasons.

Who the study is looking for

  • age \> 30 years and \<65 years
  • diagnosis of MAFLD on the basis of clinical and instrumental parameters

Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS "Saverio de Bellis"
Coordinator of this site? Confirm its status
Castellana GrotteItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.