PRIMA Project- Box for Heath and Tradition (B4HT) (PRIMA-B4HT)
Box for Health by Tradition & Innovation (B4HT): Promoting Sustainable Mediterranean Diet by Healthy Foods
Study Overview
Status
Intervention / Treatment
Detailed Description
Protocol summary The study aims to explore the effects of a tailored nutritional intervention for maintaining (normal-weight subjects) or reducing (overweight or obese subjects) body weight. In a subgroup of patients with prediabetes/T2DM, the effect of the nutritional intervention by Mediterranean lunch boxes developed in the PRIMA project on gluco-lipid homeostasis will be also evaluated. Secondary objectives are to evaluate the nutritional and functional benefits of the intervention strategies on pathogenetic factors affecting metabolic and pro-inflammatory status and intestinal permeability.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bari, Italy, 70124
- Policlinico di Bari
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects able to provide Informed Consent
- Age over 18 years
Exclusion Criteria:
- Lack of informed consent
- Pregnancy
- Chemotherapy
- Participation in other research protocols.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Lean, ongoing diet (n=40)
|
|
|
Experimental: Lean, B4HT (n= 40)
B4HT Mediterranean Lunch box
|
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, ~600 kcal)
|
|
No Intervention: OW/OB without prediabetes/T2DM ongoing diet (n=40)
|
|
|
Experimental: OW/OB without prediabetes/T2DM, B4HT (n= 40)
B4HT Mediterranean Lunch box
|
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, ~600 kcal)
|
|
No Intervention: OW/OB, with prediabetes/T2DM, ongoing diet (n=40)
|
|
|
Experimental: OW/OB with prediabetes/T2DM, B4HT (n= 40)
B4HT Mediterranean Lunch box
|
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, ~600 kcal)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (Kg)
Time Frame: From enrollment to the end of treatment at 12 weeks
|
The primary outcome isweight loss
|
From enrollment to the end of treatment at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting glucose
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Change in glycemic profile
|
From enrollment to the end of treatment at 12 weeks
|
|
Lipid profile (TC, TG, LDL, HDL)
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Change in Lipid profile
|
From enrollment to the end of treatment at 12 weeks
|
|
Liver enzymes
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Change in AST, ALT, and GGT
|
From enrollment to the end of treatment at 12 weeks
|
|
Abdominal fat storage
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Change in abdominal fat depostion
|
From enrollment to the end of treatment at 12 weeks
|
|
Liver steatosis
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Assesment of liver fat accumulation
|
From enrollment to the end of treatment at 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory markers
Time Frame: At baseline and at the end of treatment (12 weeks)
|
Assessment of serum inflammatory markers such as Interleukins and cytokines
|
At baseline and at the end of treatment (12 weeks)
|
|
Gut Microbiota
Time Frame: At baseline and at the end of treatment (12 weeks)
|
Assessment of fecal gut microbiota composition
|
At baseline and at the end of treatment (12 weeks)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRIMA2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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