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

Not Applicable

Recruiting

• Conditions: Metabolic Disease; Fatty Liver, Nonalcoholic
• Interventions: Dietary Supplement: Balanced Diet without oranges; Dietary Supplement: Dietary supplementation with fresh oranges

• Registration Number: NCT05558592
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Study Start: 2023-03-01
• Primary Completion: 2023-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control_group	Balanced Diet without oranges	-
Treatment_group	Dietary supplementation with fresh oranges	-

Primary Outcome Measures

Name	Time	Method
variation in lipidomic profile	1 year	change in membrane lipidomic profile and
changes in MAFLD score	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 Outcome Measures

Name	Time	Method
variation in antioxidant status	1 year	evaluation of antioxidant status and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD
changes in inflammatory parameters	1 year	and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD

Trial Locations

Locations (1)

IRCCS Saverio de Bellis; 🇮🇹 Castellana Grotte, Bari, Italy