Clinical trial

PRIMA Project- Box for Heath and Tradition (B4HT)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06719999

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 100 Years

SexAll

Healthy volunteersAccepted

ConditionObesity and Obesity-related Medical Conditions

Full registry criteria

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.

Treatments and study arms

B4HT Mediterranean Lunch box

Dietary Supplement

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

Primary outcomes

Weight (Kg)From enrollment to the end of treatment at 12 weeks

The primary outcome isweight loss

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Policlinico di Bari🇮🇹 Bari, Bari, Italy

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