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Clinical Trials/NCT05558592
NCT05558592RecruitingNot Applicable

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

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 site in 1 country60 target enrollmentStarted: March 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
variation in lipidomic profile

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

variation in lipidomic profile

Time Frame: 1 year

change in membrane lipidomic profile and

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

  • variation in antioxidant status(1 year)
  • changes in inflammatory parameters(1 year)

Investigators

Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Notarnicola

principal investigator, biologist

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Study Sites (1)

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