PRIMA Project- Box for Heath and Tradition (B4HT)

Not Applicable

Active, not recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06719999
• Lead Sponsor: University of Bari

Brief 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.

Detailed Description

Protocol 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.

Patients All enrolled participants (n=450, age 25-65) will undergo, following written informed consent, a 12-weeks, controlled, randomized, multicenter clinical study with multiple arms conducted on normal weight, overweight or obese subjects with or without prediabetes or other metabolic risk factors in Italy and Lebanon.

Study design Participants will be assigned to the healthy group (HG, n= 150) or to the dysmetabolic group (DG, n=300) according to a previous clinical assessment. The two groups will be comparable for age/gender composition. In each group, subjects will be randomized to continue the ongoing diet (controls) or to receive one of the lunch boxes developed in the project (L-MedFood or F-MedFood, \~600 kcal) 3-times/week during 12 weeks (treatment). In the treated groups, healthy subjects will receive the L-MedFood lunch box, the overweight/obese subjects, with or without prediabetes/T2DM, will receive the F-MedFood Box. The consumption of lunch boxes will be associated, in all enrolled subjects, with the use of iMFood, an interactive and easy-to-understand APP developed in this project and fulfilling the goal of a new Agro-Food Value Chain solution, to enable the transition to healthy and sustainable dietary behavior.

Groups

The different arms of the study will be as follows:

* Group 1: Lean, ongoing diet (n=40);

* Group 2: Lean, B4HT (n= 40);

* Group 3: OW/OB without prediabetes/T2DM ongoing diet (n=40);

* Group 4: OW/OB without prediabetes/T2DM, B4HT (n= 40);

* Group 5: OW/OB, with prediabetes/T2DM, ongoing diet (n=40);

* Group 6: OW/OB with prediabetes/T2DM, B4HT (n= 40). Participants will have follow-up phone/physical visits every third week (4 visits). These subjects will receive Fat-Dysmetabolic Box (3-times/week) and APP iMFood with standard-of-care pharmacological treatments.

Duration The study is planned to last 12 weeks.

Outputs In all arms of the study, the primary outcomes are weight loss and satisfaction index. Secondary outcomes include changes in gluco-lipid homeostasis and in visceral and liver fat quantitative ultrasonography, adherence to Mediterranean diet (assessed and monitored by the validated score MEDI-LITE). Exploratory analyses will include analyses of inflammatory status, intestinal permeability as assessed by oral quadruple test ingestion, gut microbiota profile and metabolomic analysis. Cause-and-effect relationships between B4HT and risk reduction and decrease in obesity rate and other metabolic abnormalities.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight (Kg)	From enrollment to the end of treatment at 12 weeks	The primary outcome isweight loss

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	From enrollment to the end of treatment at 12 weeks	Change in glycemic profile
Lipid profile (TC, TG, LDL, HDL)	From enrollment to the end of treatment at 12 weeks	Change in Lipid profile
Liver enzymes	From enrollment to the end of treatment at 12 weeks	Change in AST, ALT, and GGT
Abdominal fat storage	From enrollment to the end of treatment at 12 weeks	Change in abdominal fat depostion
Liver steatosis	From enrollment to the end of treatment at 12 weeks	Assesment of liver fat accumulation

Trial Locations

Locations (1)

Policlinico di Bari; 🇮🇹 Bari, Italy