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

NCT05558592 | Completed

• 1 other identifier: RC2022_prg.15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disease; Fatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• variation in antioxidant status

  1 year

• changes in inflammatory parameters

  1 year

Study Arms (2)

Treatment_group

EXPERIMENTAL

Dietary Supplement: Dietary supplementation with fresh oranges

Control_group

ACTIVE COMPARATOR

Dietary Supplement: Balanced Diet without oranges

Interventions

Balanced Diet without oranges DIETARY_SUPPLEMENT

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.

Control_group

Dietary supplementation with fresh oranges DIETARY_SUPPLEMENT

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".

Treatment_group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 30 years and \<65 years
• diagnosis of MAFLD on the basis of clinical and instrumental parameters

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Valeria Tutino: collaborator
• Cisternino Anna Maria: collaborator
• Valentina De Nunzio: collaborator
• Roberta Rinaldi: collaborator

Study Sites (1)

IRCCS Saverio de Bellis

Castellana Grotte, BARI, 70013, Italy

Location

Related Publications (6)

• 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.jnutbio.2017.08.012. Epub 2017 Sep 1.

  PMID: 29040837 RESULT

• 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 Morphology in Human Colon Cancer Cell Lines. Molecules. 2020 Jul 23;25(15):3352. doi: 10.3390/molecules25153352.

  PMID: 32718061 RESULT

• 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 Modulation of Gastrointestinal Cancer-Related Pathways. Mol Nutr Food Res. 2021 Nov;65(21):e2100428. doi: 10.1002/mnfr.202100428. Epub 2021 Sep 21.

  PMID: 34495579 RESULT

• 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.

  PMID: 26965492 RESULT

• 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 2009 Dec 29.

  PMID: 20104270 RESULT

• Notarnicola M, Tutino V, De Nunzio V, Cisternino AM, Cofano M, Donghia R, Giannuzzi V, Zappimbulso M, Milella RA, Giannelli G, Fontana L. Daily Orange Consumption Reduces Hepatic Steatosis Prevalence in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease: Exploratory Outcomes of a Randomized Clinical Trial. Nutrients. 2024 Sep 20;16(18):3191. doi: 10.3390/nu16183191.

  PMID: 39339791 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Non-alcoholic Fatty Liver Disease

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, biologist

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: March 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: December 31, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)