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

Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558592
• Other study ID #: RC2022_prg.15
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: Maria Notarnicola, DSc
• Phone: 0804994342
• Email: maria.notarnicola[@]irccsdebellis.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Liver Diseases
• Metabolic Disease
• Metabolic Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Dietary supplementation with fresh oranges
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".
• Balanced Diet without oranges
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.

Locations

Country	Name	City	State
Italy	IRCCS Saverio de Bellis	Castellana Grotte	Bari

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis	Cisternino Anna Maria, Roberta Rinaldi, Valentina De Nunzio, Valeria Tutino

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Akiyama S, Katsumata S, Suzuki K, Ishimi Y, Wu J, Uehara M. Dietary hesperidin exerts hypoglycemic and hypolipidemic effects in streptozotocin-induced marginal type 1 diabetic rats. J Clin Biochem Nutr. 2010 Jan;46(1):87-92. doi: 10.3164/jcbn.09-82. Epub — View Citation

Ammollo CT, Semeraro F, Milella RA, Antonacci D, Semeraro N, Colucci M. Grape intake reduces thrombin generation and enhances plasma fibrinolysis. Potential role of circulating procoagulant microparticles. J Nutr Biochem. 2017 Dec;50:66-73. doi: 10.1016/j — View Citation

Simpson EJ, Mendis B, Macdonald IA. Orange juice consumption and its effect on blood lipid profile and indices of the metabolic syndrome; a randomised, controlled trial in an at-risk population. Food Funct. 2016 Apr;7(4):1884-91. doi: 10.1039/c6fo00039h. — View Citation

Tutino V, De Nunzio V, Milella RA, Gasparro M, Cisternino AM, Gigante I, Lanzilotta E, Iacovazzi PA, Lippolis A, Lippolis T, Caruso MG, Notarnicola M. Impact of Fresh Table Grape Intake on Circulating microRNAs Levels in Healthy Subjects: A Significant Mo — View Citation

Tutino V, Gigante I, Milella RA, De Nunzio V, Flamini R, De Rosso M, Scavo MP, Depalo N, Fanizza E, Caruso MG, Notarnicola M. Flavonoid and Non-Flavonoid Compounds of Autumn Royal and Egnatia Grape Skin Extracts Affect Membrane PUFA's Profile and Cell Mor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation in lipidomic profile	change in membrane lipidomic profile and	1 year
Primary	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	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
Secondary	changes in inflammatory parameters	and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD	1 year