NCT05558592

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

Completed NA Last updated 25 March 2026

What this trial tests

NA trial testing Dietary supplementation with fresh oranges in Metabolic Disease in 60 participants. Completed in 31 December 2024.

Timeline

1 March 2023

Primary endpoint
30 July 2023

31 December 2024

Quick facts

Lead sponsor	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 March 2023
Primary completion	30 July 2023
Estimated completion	31 December 2024
Sites	1 location across Italy

Drugs / interventions tested

• Dietary supplementation with fresh oranges
• Balanced Diet without oranges

Conditions studied

• Metabolic Disease — all drugs for Metabolic Disease →
• Fatty Liver, Nonalcoholic — all drugs for Fatty Liver, Nonalcoholic →

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Who can join

Adults 30 to 65, any sex, with Metabolic Disease or Fatty Liver, Nonalcoholic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Daily Orange Consumption Reduces Hepatic Steatosis Prevalence in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease: Exploratory Outcomes of a Randomized Clinical Trial.
   Notarnicola M, Tutino V, De Nunzio V, Cisternino AM, et al · · 2024 · cited 13× · PMID 39339791 · DOI 10.3390/nu16183191
2. Metataxonomics and Metabolomics Profiles in Metabolic Dysfunction-Associated Fatty Liver Disease Patients on a "Navelina" Orange-Enriched Diet.
   Calabrese FM, Aloisio Caruso E, De Nunzio V, Celano G, et al · · 2024 · cited 4× · PMID 39458536 · DOI 10.3390/nu16203543
3. Effect of 4-Week Consumption of "Navelina" Oranges on Serum Lipid Profile in Patients with MASLD: Evidence from a Randomized Clinical Trial.
   De Nunzio V, Pinto G, Guido D, Aloisio Caruso E, et al · · 2026 · PMID 42075067 · DOI 10.3390/nu18081254
4. Alcohol-Related Liver Disease and Metabolic Dysfunction-Associated Steatotic Liver Disease: Molecular Pathogenesis and Therapeutic Interventions.
   Tan Y, Hu Y, Yang Y, Chu H. · · 2025 · PMID 41362700 · DOI 10.1002/mco2.70532