Obesity and Obesity-related Medical ConditionsPRIMA-B4HTNCT06719999
PRIMA Project- Box for Heath and Tradition (B4HT)
A study testing B4HT Mediterranean Lunch box in people with Obesity and Obesity-related Medical Conditions, run by University of Bari at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- B4HT Mediterranean Lunch box
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects able to provide Informed Consent
- Age over 18 years
Who cannot join
- Lack of informed consent
- Pregnancy
- Chemotherapy
- Participation in other research protocols.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Box for Health by Tradition & Innovation (B4HT): Promoting Sustainable Mediterranean Diet by Healthy Foods
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.
Read the 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.
- Being tested
- B4HT Mediterranean Lunch box
- Keywords
- Mediterranean lunch boxes, Obesity, Diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B4HT Mediterranean Lunch boxDietary supplement
lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, ~600 kcal)
| Study group | Role | What they receive |
|---|---|---|
| Lean, ongoing diet (n=40) | No intervention | Not described |
| Lean, B4HT (n= 40) | Experimental | B4HT Mediterranean Lunch box Receives: Dietary Supplement: B4HT Mediterranean Lunch box |
| OW/OB without prediabetes/T2DM ongoing diet (n=40) | No intervention | Not described |
| OW/OB without prediabetes/T2DM, B4HT (n= 40) | Experimental | B4HT Mediterranean Lunch box Receives: Dietary Supplement: B4HT Mediterranean Lunch box |
| OW/OB, with prediabetes/T2DM, ongoing diet (n=40) | No intervention | Not described |
| OW/OB with prediabetes/T2DM, B4HT (n= 40) | Experimental | B4HT Mediterranean Lunch box Receives: Dietary Supplement: B4HT Mediterranean Lunch box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (Kg)
The primary outcome isweight loss
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Fasting glucose
Change in glycemic profile
Measured: From enrollment to the end of treatment at 12 weeks
Lipid profile (TC, TG, LDL, HDL)
Change in Lipid profile
Measured: From enrollment to the end of treatment at 12 weeks
Liver enzymes
Change in AST, ALT, and GGT
Measured: From enrollment to the end of treatment at 12 weeks
Abdominal fat storage
Change in abdominal fat depostion
Measured: From enrollment to the end of treatment at 12 weeks
Liver steatosis
Assesment of liver fat accumulation
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719999
- Sponsor's protocol ID
- PRIMA2023
- Acronym
- PRIMA-B4HT
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38891828Santoro 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.
PubMed 38490931Abdallah 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.
PubMed 37203871Khalil 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.
PubMed 36829984Khalil 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.
PubMed 35956289Portincasa 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.
PubMed 35052763
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Box for Health by Tradition & Innovation (B4HT): Promoting Sustainable Mediterranean Diet by Healthy Foods
- ClinicalTrials.gov ID
- NCT06719999
- Acronym / sponsor ID
- PRIMA-B4HT / PRIMA2023
- Keywords
- Mediterranean lunch boxes, Obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lean, ongoing diet (n=40) | No intervention | – |
| Lean, B4HT (n= 40) | Experimental | Dietary Supplement: B4HT Mediterranean Lunch boxB4HT Mediterranean Lunch box |
| OW/OB without prediabetes/T2DM ongoing diet (n=40) | No intervention | – |
| OW/OB without prediabetes/T2DM, B4HT (n= 40) | Experimental | Dietary Supplement: B4HT Mediterranean Lunch boxB4HT Mediterranean Lunch box |
| OW/OB, with prediabetes/T2DM, ongoing diet (n=40) | No intervention | – |
| OW/OB with prediabetes/T2DM, B4HT (n= 40) | Experimental | Dietary Supplement: B4HT Mediterranean Lunch boxB4HT Mediterranean Lunch box |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects able to provide Informed Consent
- Age over 18 years
Key exclusion criteria (4 listed)
- Lack of informed consent
- Pregnancy
- Chemotherapy
- Participation in other research protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B4HT Mediterranean Lunch boxlunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, ~600 kcal) | Dietary supplement | Lean, B4HT (n= 40), OW/OB with prediabetes/T2DM, B4HT (n= 40), OW/OB without prediabetes/T2DM, B4HT (n= 40) |
Primary outcome
Weight (Kg)
Time frame: From enrollment to the end of treatment at 12 weeks
The primary outcome isweight loss
5 secondary outcomes
Fasting glucose
Time frame: 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
Liver enzymes
Time frame: 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
Liver steatosis
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 38891828Portincasa 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.
- Background: PubMed 38490931Santoro 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.
- Background: PubMed 37203871Abdallah 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.
- Background: PubMed 36829984Khalil 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.
- Background: PubMed 35956289Khalil 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.
- Background: PubMed 35052763Portincasa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B4HT Mediterranean Lunch box in people with Obesity and Obesity-related Medical Conditions, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (Kg) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06719999, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.