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

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05558592
• Collaborator: Cisternino Anna Maria (Other), Valeria Tutino (Other), Valentina De Nunzio (Other), Roberta Rinaldi (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.8
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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	Intervention/Treatment	Phase
Metabolic Disease; Fatty Liver, Nonalcoholic	Dietary Supplement: Dietary supplementation with fresh oranges; Dietary Supplement: Balanced Diet without oranges	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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)
• Anticipated Study Start Date: Jan 7, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment_group	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".
Active Comparator: Control_group	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

1. variation in lipidomic profile [1 year]

   change in membrane lipidomic profile and

2. changes in MAFLD score [1 year]

   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.

Secondary Outcome Measures

1. variation in antioxidant status [1 year]

   evaluation of antioxidant status and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD

2. changes in inflammatory parameters [1 year]

   and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Saverio de Bellis	Castellana Grotte	Bari	Italy	70013

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Notarnicola, principal investigator, biologist, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• ClinicalTrials.gov Identifier: NCT05558592
• Other Study ID Numbers: RC2022_prg.15
• First Posted: Sep 28, 2022
• Last Update Posted: Sep 28, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Diseases

Study Results

No Results Posted as of Sep 28, 2022