Clinical trial NCT05447351: Beneficial Effects of Dietary and Lifestyle Change in Overweight and Obese Subjects
Official title: Effects of Personalized Dietary and Lifestyle Treatments on the Reduction of Cardiovascular and Metabolic Risk in Overweight and Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight and Obesity
Cardiovascular Diseases
Metabolic Syndrome
Non-Alcoholic Fatty Liver Disease
Keywords: Overweight and Obesity
Cardiovascular diseases
Mediterranean Diet
Lifestyle
Physical activity
Metabolic disorders
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrolled in the study will be 200 overweight or obese adult patients (comparable sex ratio) entering the outpatient clinic for metabolic diseases.

Subjects will be randomized in two groups (i.e., n=100 treated and n=100 controls). For an unpaired t-test (i.e., comparison of two groups), 50 is the minimum sample size needed in each group to obtain a power of 0.80, when the effect size is medium and a significance level of 0.05 is employed.

Brief summary: Obesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults. In 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (WHO). In the EU-27 (Eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese. The growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes). A transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.

Detailed description: The study is aimed to measure the beneficial effects of specific dietary models (i.e., Mediterranean Diet) and healthy lifestyle (i.e., controlled physical activity) in reducing body/organ fat accumulation and in the improvement of metabolic health. A comprehensive and combined analysis of these effects (mainly following personalized strategies and close follow-up) on pathogenic mechanisms affecting cardiovascular and metabolic risk, pro-inflammatory status and intestinal permeability in the medium-long term is still lacking.

During the study, overweight/obese subjects (i.e. Body Mass Index equal or higher to 25Kg/m2) will be assessed at basal and monitored during a 24 months follow-up

Eligibility criteria: Inclusion Criteria:

* overweight or obese patients
* patients who able to sign informed consent

Exclusion Criteria:

* failure to sign informed consent;
* inclusion in other research protocols
* Normal weight patients

Primary outcomes:
measure: Effects of treatments on Body Mass Index and waist circumference
timeFrame: 24 months
measure: Effects of treatments on visceral fat
timeFrame: 24 months
Secondary outcomes:
measure: Change in metabolic indices and in hormones involved in the regulation of glucose metabolism
timeFrame: 24 months
measure: Change in hormones involved in nutrient sensing
timeFrame: 24 months
measure: Effects of microbiota and metabolome
timeFrame: 24 months
measure: Effects on intestinal permeability
timeFrame: 24 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
state: BA
Study officials:
References:
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