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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)

Primary Purpose

Metabolic Disease, Fatty Liver, Nonalcoholic

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dietary supplementation with fresh oranges
Balanced Diet without oranges
Sponsored by
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Disease

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Saverio de BellisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment_group

Control_group

Arm Description

Outcomes

Primary Outcome Measures

variation in lipidomic profile
change in membrane lipidomic profile and
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2022
Last Updated
March 9, 2023
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborators
Cisternino Anna Maria, Valeria Tutino, Valentina De Nunzio, Roberta Rinaldi
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1. Study Identification

Unique Protocol Identification Number
NCT05558592
Brief Title
Evaluation of the Effects of Orange Consumption on Carbohydrate and Lipid Metabolism in Subjects With MAFLD (Metabolic Associated Fatty Liver Disease)
Official Title
Evaluation of the Effects of Orange Consumption on Carbohydrate and Lipid Metabolism in Subjects With MAFLD (Metabolic Associated Fatty Liver Disease)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborators
Cisternino Anna Maria, Valeria Tutino, Valentina De Nunzio, Roberta Rinaldi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Fatty Liver, Nonalcoholic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment_group
Arm Type
Experimental
Arm Title
Control_group
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplementation with fresh oranges
Intervention Description
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".
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced Diet without oranges
Intervention Description
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.
Primary Outcome Measure Information:
Title
variation in lipidomic profile
Description
change in membrane lipidomic profile and
Time Frame
1 year
Title
changes in MAFLD score
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
variation in antioxidant status
Description
evaluation of antioxidant status and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD
Time Frame
1 year
Title
changes in inflammatory parameters
Description
and improvement of inflammatory parameters in order to reduce metabolic risk in subjects with MAFLD
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Notarnicola, DSc
Phone
0804994342
Email
maria.notarnicola@irccsdebellis.it
Facility Information:
Facility Name
IRCCS Saverio de Bellis
City
Castellana Grotte
State/Province
Bari
ZIP/Postal Code
70013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Notarnicola, Dsc
Phone
0804994342
Email
maria.notarnicola@irccsdebellis.it
First Name & Middle Initial & Last Name & Degree
Valeria Tutino, Dsc
Phone
0804994651
Email
valeria.tutino@irccsdebellis.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29040837
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.jnutbio.2017.08.012. Epub 2017 Sep 1.
Results Reference
result
PubMed Identifier
32718061
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 Morphology in Human Colon Cancer Cell Lines. Molecules. 2020 Jul 23;25(15):3352. doi: 10.3390/molecules25153352.
Results Reference
result
PubMed Identifier
34495579
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 Modulation of Gastrointestinal Cancer-Related Pathways. Mol Nutr Food Res. 2021 Nov;65(21):e2100428. doi: 10.1002/mnfr.202100428. Epub 2021 Sep 21.
Results Reference
result
PubMed Identifier
26965492
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.
Results Reference
result
PubMed Identifier
20104270
Citation
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.
Results Reference
result

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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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