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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Metabolic Disease, Fatty Liver, Nonalcoholic

Intervention / Treatment
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* Dietary Supplement: Dietary supplementation with fresh oranges
* Dietary Supplement: Balanced Diet without oranges


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment_group<br> | Dietary Supplement: Dietary supplementation with fresh oranges<br>* 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.<br>|
| Active Comparator: Control_group<br> | Dietary Supplement: Balanced Diet without oranges<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation in lipidomic profile | change in membrane lipidomic profile and | 1 year | 
| changes in MAFLD score | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation in antioxidant status | evaluation of antioxidant status and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD | 1 year | 
| changes in inflammatory parameters | and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD | 1 year |