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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05558592
Enrollment
60
Registered
2022-09-28
Start date
2023-03-01
Completion date
2024-12-31
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Nonalcoholic, Metabolic Disease

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.

Interventions

DIETARY_SUPPLEMENTDietary supplementation with fresh oranges

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".

DIETARY_SUPPLEMENTBalanced Diet without oranges

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.

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead SponsorOTHER
Cisternino Anna Maria
CollaboratorUNKNOWN
Valeria Tutino
CollaboratorUNKNOWN
Valentina De Nunzio
CollaboratorUNKNOWN
Roberta Rinaldi
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
variation in lipidomic profile1 yearchange in membrane lipidomic profile and
changes in MAFLD score1 yearchanges 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

MeasureTime frameDescription
variation in antioxidant status1 yearevaluation of antioxidant status and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD
changes in inflammatory parameters1 yearand improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026