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NCT05558592 | Recruiting | Metabolic Disease


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

Saverio de Bellis Hospital Specializing in Gastroenterology

Information provided by (Responsible Party):

Maria Notarnicola

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.

Condition or disease

Metabolic Disease

Fatty Liver, Nonalcoholic

Intervention/treatment

Dietary supplementation with fresh oranges

Balanced Diet without oranges

Phase

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
Criteria
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.

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

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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)

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Locations


Recruiting

Italy, Bari

IRCCS Saverio de Bellis

Castellana Grotte, Bari, Italy, 70013

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