PRIMA Project- Box for Heath and Tradition (B4HT)

NCT06719999 | Active Not Recruiting

• 1 other identifier: PRIMA2023
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Mediterranean lunch boxes; Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• Weight (Kg)

  The primary outcome isweight loss

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

• Fasting glucose

  From enrollment to the end of treatment at 12 weeks

• Lipid profile (TC, TG, LDL, HDL)

  From enrollment to the end of treatment at 12 weeks

• Liver enzymes

  From enrollment to the end of treatment at 12 weeks

• Abdominal fat storage

  From enrollment to the end of treatment at 12 weeks

• Liver steatosis

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (2)

• Inflammatory markers

  At baseline and at the end of treatment (12 weeks)

• Gut Microbiota

  At baseline and at the end of treatment (12 weeks)

Study Arms (6)

Lean, ongoing diet (n=40)

NO INTERVENTION

Lean, B4HT (n= 40)

EXPERIMENTAL

B4HT Mediterranean Lunch box

Dietary Supplement: B4HT Mediterranean Lunch box

OW/OB without prediabetes/T2DM ongoing diet (n=40)

NO INTERVENTION

OW/OB without prediabetes/T2DM, B4HT (n= 40)

EXPERIMENTAL

B4HT Mediterranean Lunch box

Dietary Supplement: B4HT Mediterranean Lunch box

OW/OB, with prediabetes/T2DM, ongoing diet (n=40)

NO INTERVENTION

OW/OB with prediabetes/T2DM, B4HT (n= 40)

EXPERIMENTAL

B4HT Mediterranean Lunch box

Dietary Supplement: B4HT Mediterranean Lunch box

Interventions

B4HT Mediterranean Lunch box DIETARY_SUPPLEMENT

lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, \~600 kcal)

Lean, B4HT (n= 40); OW/OB with prediabetes/T2DM, B4HT (n= 40); OW/OB without prediabetes/T2DM, B4HT (n= 40)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to provide Informed Consent
• Age over 18 years

You may not qualify if:

• Lack of informed consent
• Pregnancy
• Chemotherapy
• Participation in other research protocols.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Policlinico di Bari

Bari, Bari, 70124, Italy

Location

Related Publications (6)

• 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.

  PMID: 38891828 BACKGROUND

• 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.

  PMID: 38490931 BACKGROUND

• 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.

  PMID: 37203871 BACKGROUND

• 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.

  PMID: 36829984 BACKGROUND

• 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.

  PMID: 35956289 BACKGROUND

• 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.

  PMID: 35052763 BACKGROUND

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

IT (1)