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PRIMA Project- Box for Heath and Tradition (B4HT)

NCT06719999 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-12-06

No results posted yet for this 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.

Conditions

  • Obesity and Obesity-related Medical Conditions

Interventions

DIETARY_SUPPLEMENT

B4HT Mediterranean Lunch box

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

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-12-01
Completion
2026-02-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719999 on ClinicalTrials.gov