Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05558592
Other study ID # RC2022_prg.15
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06188728 - Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Not yet recruiting NCT05461144 - AI Models for Non-invasive Glycaemic Event Detection Using ECG in Type 1 Diabetics
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Active, not recruiting NCT05505994 - The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin Phase 3
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03675360 - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial N/A
Recruiting NCT05711758 - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Recruiting NCT05112029 - Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Completed NCT04854603 - Dairy Products With Reduced Sugar and Blood Glucose N/A
Recruiting NCT06024291 - Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial N/A
Recruiting NCT04904601 - Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects N/A
Recruiting NCT04109586 - Diet and Fat Mass After Traumatic Spinal Cord Injury N/A
Recruiting NCT06009653 - Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity Phase 4
Completed NCT03067012 - Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients N/A
Recruiting NCT03309423 - Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU? N/A