Clinical Trial

PRIMA Project- Box for Heath and Tradition (B4HT)

Study acronym: PRIMA-B4HT
Active, Not Recruiting
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Record status
This record was last updated December 6, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06719999
Lead Sponsor University of Bari
Conditions Obesity and Obesity-related Medical Conditions
Enrollment 450 participants
Start Date 2024-09-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-06