Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
450 participants
INTERVENTIONAL
2024-09-01
2026-02-01
Brief Summary
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Detailed Description
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Patients All enrolled participants (n=450, age 25-65) will undergo, following written informed consent, a 12-weeks, controlled, randomized, multicenter clinical study with multiple arms conducted on normal weight, overweight or obese subjects with or without prediabetes or other metabolic risk factors in Italy and Lebanon.
Study design Participants will be assigned to the healthy group (HG, n= 150) or to the dysmetabolic group (DG, n=300) according to a previous clinical assessment. The two groups will be comparable for age/gender composition. In each group, subjects will be randomized to continue the ongoing diet (controls) or to receive one of the lunch boxes developed in the project (L-MedFood or F-MedFood, \~600 kcal) 3-times/week during 12 weeks (treatment). In the treated groups, healthy subjects will receive the L-MedFood lunch box, the overweight/obese subjects, with or without prediabetes/T2DM, will receive the F-MedFood Box. The consumption of lunch boxes will be associated, in all enrolled subjects, with the use of iMFood, an interactive and easy-to-understand APP developed in this project and fulfilling the goal of a new Agro-Food Value Chain solution, to enable the transition to healthy and sustainable dietary behavior.
Groups
The different arms of the study will be as follows:
* Group 1: Lean, ongoing diet (n=40);
* Group 2: Lean, B4HT (n= 40);
* Group 3: OW/OB without prediabetes/T2DM ongoing diet (n=40);
* Group 4: OW/OB without prediabetes/T2DM, B4HT (n= 40);
* Group 5: OW/OB, with prediabetes/T2DM, ongoing diet (n=40);
* Group 6: OW/OB with prediabetes/T2DM, B4HT (n= 40). Participants will have follow-up phone/physical visits every third week (4 visits). These subjects will receive Fat-Dysmetabolic Box (3-times/week) and APP iMFood with standard-of-care pharmacological treatments.
Duration The study is planned to last 12 weeks.
Outputs In all arms of the study, the primary outcomes are weight loss and satisfaction index. Secondary outcomes include changes in gluco-lipid homeostasis and in visceral and liver fat quantitative ultrasonography, adherence to Mediterranean diet (assessed and monitored by the validated score MEDI-LITE). Exploratory analyses will include analyses of inflammatory status, intestinal permeability as assessed by oral quadruple test ingestion, gut microbiota profile and metabolomic analysis. Cause-and-effect relationships between B4HT and risk reduction and decrease in obesity rate and other metabolic abnormalities.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lean, ongoing diet (n=40)
No interventions assigned to this group
Lean, B4HT (n= 40)
B4HT Mediterranean Lunch box
B4HT Mediterranean Lunch box
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, \~600 kcal)
OW/OB without prediabetes/T2DM ongoing diet (n=40)
No interventions assigned to this group
OW/OB without prediabetes/T2DM, B4HT (n= 40)
B4HT Mediterranean Lunch box
B4HT Mediterranean Lunch box
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, \~600 kcal)
OW/OB, with prediabetes/T2DM, ongoing diet (n=40)
No interventions assigned to this group
OW/OB with prediabetes/T2DM, B4HT (n= 40)
B4HT Mediterranean Lunch box
B4HT Mediterranean Lunch box
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, \~600 kcal)
Interventions
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B4HT Mediterranean Lunch box
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, \~600 kcal)
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years
Exclusion Criteria
* Pregnancy
* Chemotherapy
* Participation in other research protocols.
18 Years
100 Years
ALL
Yes
Sponsors
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University of Bari
OTHER
Responsible Party
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piero portincasa
Full Professor
Locations
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Policlinico di Bari
Bari, Bari, Italy
Countries
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References
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Portincasa P, Khalil M, Mahdi L, Perniola V, Idone V, Graziani A, Baffy G, Di Ciaula A. Metabolic Dysfunction-Associated Steatotic Liver Disease: From Pathogenesis to Current Therapeutic Options. Int J Mol Sci. 2024 May 22;25(11):5640. doi: 10.3390/ijms25115640.
Santoro S, Khalil M, Abdallah H, Farella I, Noto A, Dipalo GM, Villani P, Bonfrate L, Di Ciaula A, Portincasa P. Early and accurate diagnosis of steatotic liver by artificial intelligence (AI)-supported ultrasonography. Eur J Intern Med. 2024 Jul;125:57-66. doi: 10.1016/j.ejim.2024.03.004. Epub 2024 Mar 14.
Abdallah H, Khalil M, Farella I, JohnBritto JS, Lanza E, Santoro S, Garruti G, Portincasa P, Di Ciaula A, Bonfrate L. Ramadan intermittent fasting reduces visceral fat and improves gastrointestinal motility. Eur J Clin Invest. 2023 Sep;53(9):e14029. doi: 10.1111/eci.14029. Epub 2023 May 19.
Khalil M, Abdallah H, Razuka-Ebela D, Calasso M, De Angelis M, Portincasa P. The Impact of Za'atar Antioxidant Compounds on the Gut Microbiota and Gastrointestinal Disorders: Insights for Future Clinical Applications. Antioxidants (Basel). 2023 Feb 9;12(2):426. doi: 10.3390/antiox12020426.
Khalil M, Shanmugam H, Abdallah H, John Britto JS, Galerati I, Gomez-Ambrosi J, Fruhbeck G, Portincasa P. The Potential of the Mediterranean Diet to Improve Mitochondrial Function in Experimental Models of Obesity and Metabolic Syndrome. Nutrients. 2022 Jul 28;14(15):3112. doi: 10.3390/nu14153112.
Portincasa P, Bonfrate L, Khalil M, Angelis M, Calabrese FM, D'Amato M, Wang DQ, Di Ciaula A. Intestinal Barrier and Permeability in Health, Obesity and NAFLD. Biomedicines. 2021 Dec 31;10(1):83. doi: 10.3390/biomedicines10010083.
Other Identifiers
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PRIMA2023
Identifier Type: -
Identifier Source: org_study_id