PRIMA Project- Box for Heath and Tradition (B4HT)

NCT06719999 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Bari

Phase

Not applicable

Started

2024-09-01

Last updated

2024-12-06

Condition(s) studied

Obesity and Obesity-related Medical Conditions

Investigational drug(s) / intervention(s)

B4HT Mediterranean Lunch box

B4HT Mediterranean Lunch box: lunch boxes developed in the PRIMA project (L-MedFood or F-MedFood, \~600 kcal)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Weight (Kg) — From enrollment to the end of treatment at 12 weeks
The primary outcome isweight loss

Trial sites (1)

Facility	City	Region	Status
Policlinico di Bari	Bari	Bari

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06719999 on ClinicalTrials.gov ↗ ← All trials in Italy