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 Bellis

Status: Enrolling

Conditions: Fatty Liver, Nonalcoholic; Metabolic Disease

Treatments: Dietary Supplement: Balanced Diet without oranges; Dietary Supplement: Dietary supplementation with fresh oranges

Study type: Interventional

Funder types: Other

Identifiers

NCT05558592

RC2022_prg.15

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Treatment_group

Experimental group

Treatment:

Dietary Supplement: Dietary supplementation with fresh oranges

Control_group

Active Comparator group

Treatment:

Dietary Supplement: Balanced Diet without oranges