Saverio de Bellis Hospital Specializing in Gastroenterology
Maria Notarnicola
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.
Metabolic Disease
Fatty Liver, Nonalcoholic
Dietary supplementation with fresh oranges
Balanced Diet without oranges
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Evaluation of the Effects of Orange Consumption on Carbohydrate and Lipid Metabolism in Subjects With MAFLD (Metabolic Associated Fatty Liver Disease) |
Actual Study Start Date : | March 1, 2023 |
Estimated Primary Completion Date : | July 30, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment_group |
Dietary Supplement: Dietary supplementation with fresh oranges |
Active Comparator: Control_group |
Dietary Supplement: Balanced Diet without oranges |
Ages Eligible for Study: | 30 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Recruiting
IRCCS Saverio de Bellis
Castellana Grotte, Bari, Italy, 70013