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OpenTrials
Completed

NCT Number: NCT05558592

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Saverio de Bellis

Castellana Grotte, BARI, 70013, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • gastroesophageal reflux diseases;
  • inflammatory bowel diseases; oncological diseases;
  • serious medical conditions that may impair participation in the trial;
  • people who follow a special diet or who use anticoagulants;
  • subjects unable to follow a diet for religious or other reasons.

Treatment and study plan

Dietary supplementation with fresh oranges

Dietary Supplement

the subjects enrolled in this group, will have to consume 400gr of oranges "Navelina" net of waste / day / per person for a month. The oranges will be provided, to each participant, by the IRCCS "Saverio de Bellis".

Balanced Diet without oranges

Dietary Supplement

the subjects enrolled in this group, will have to consume 400 gr of fruit (with the exception of citrus fruits) net of waste / day / per person for a month.

Primary outcomes

  1. variation in lipidomic profile

    Time frame: 1 year

    change in membrane lipidomic profile and

  2. changes in MAFLD score

    Time frame: 1 year

    changes in MAFLD score at the end of the treatment period from baseline - this score is evaluated as change in grade of steatosis Measurement of steatosis: The Controlled Attenuation Parameter (CAP) measurement was performed by a vibration-controlled elastography (VCTE) implemented on FibroScan® (Echosens, Paris, France). The CAP score is measured in decibels per meter (dB/m). Values < 215 dB/m corresponded to the absence of NAFLD; values between 215 and 250 dB/m indicated a mild NAFLD; values between 251 and 299 dB/m indicated a moderate NAFLD, while values ≥ 300 dB/m corresponded to a severe NAFLD.

Secondary outcomes

  1. variation in antioxidant status

    Time frame: 1 year

    evaluation of antioxidant status and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD

  2. changes in inflammatory parameters

    Time frame: 1 year

    and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Collaborators

  • Cisternino Anna Maria
  • Roberta Rinaldi
  • Valentina De Nunzio
  • Valeria Tutino

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 28, 2022
Registry last updated
Mar 25, 2026

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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