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NCT06719999Active, not recruiting

PRIMA Project- Box for Heath and Tradition (B4HT)

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

Source: ClinicalTrials.gov · Last updated 6 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
450 (estimated)
First submitted
2 Dec 2024
Start date
1 Sept 2024
Primary completion date
1 Dec 2025
Lead sponsor
University of Bari
Diseases
Obesity
NCT number
NCT06719999

What you commit to

  • Study type: Interventional
  • Planned participants: 450
  • From 1 Sept 2024 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chemotherapy

Other

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

Who the study is looking for

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

Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Policlinico di Bari
Coordinator of this site? Confirm its status
BariItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.