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ACTIVE NOT RECRUITING
NCT06719999
NA

PRIMA Project- Box for Heath and Tradition (B4HT)

Sponsor: University of Bari

View on ClinicalTrials.gov

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.

Official title: Box for Health by Tradition & Innovation (B4HT): Promoting Sustainable Mediterranean Diet by Healthy Foods

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-09-01

Completion Date

2026-02-01

Last Updated

2024-12-06

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

B4HT Mediterranean Lunch box

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

Locations (1)

Policlinico di Bari

Bari, Bari, Italy