Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study
Condition: Obesity; Overweight
MeSH terms: Overweight; Noncommunicable Diseases
Study type: Interventional

Summary: 
      Non-communicable diseases (NCD) are the main health challenge in industrialized countries.
      However, these diseases are preventable if an intervention based on lifestyle is implemented
      at the population level. Diet has a great impact on the onset and progression of NCD. In this
      regard, ultra-processed food (UPF) consumption has been related to higher morbidity and
      mortality. UPF are defined as "formulations made mostly or entirely from substances derived
      from foods and additives, with little if any intact unprocessed or minimally processed foods"
      (NOVA definition). UPF are rich in saturated fats and additives and poor in fiber other
      nutrients. UPF consumption has raised in the last decades in the industrialized countries and
      this increase has been associated with higher prevalence of metabolic disorders such as
      diabetes, obesity, metabolic syndrome, cardiovascular disease, and cancer. However,
      mechanisms that link UPF consumption with NCD are poorly understood and clinical trials are
      needed to unravel these mechanisms and how to impact on them through lifestyle interventions.
      The investigators have previously identified DNA methylation marks associated with UPF
      consumption. DNA methylation marks are modifiable. The aim of the study is to assay if DNA
      methylation marks related to UPF consumption are reversible by reducing UPF consumption in a
      population of adults with overweight or obesity and with a high basal UPF consumption (>35%
      of total food consumption in g/day).
    

Detailed description: 
      The investigators propose a controlled, randomized, parallel groups intervention study based
      on nutritional counseling to reduce UPF consumption. Eligible participants are adults (18-50
      years old), men and women, with overweight or obesity (BMI 25-40 Kg/m2) with a high basal
      consumption of UPF (>35% of total intake in g/day).

      Recruited participants will be randomly allocated into a control group or an intervention
      group. Participants in the control group will be provided with nutritional guidelines to
      follow a healthy diet based on a Mediterranean diet. Participants in the intervention group
      will follow a nutritional intervention program aimed to reduce UPF consumption. Nutritional
      intervention will not modify basal caloric intake but will record energy intake along the
      intervention. Nutritional counseling will be based on nutritional educational material such
      as encourage and discourage food items, recipes, menus and food shopping lists based on
      unprocessed or minimally processed foods.

      Total intervention will last 6 months for both groups. During the intervention phase, a
      monthly interview with nutritionist/dietitian is scheduled. Face-to-face interviews will be
      carried out in months 2 and 4. Phone interviews will be carried out in months 1, 3 and 5. In
      the baseline and final visits (months 0 and 6) a sample and data collection will be
      performed.

      Data collected will include general socio-demographical data (age, sex, educational level,
      working status, civil status, rural/urban status), lifestyle data (smoking habits, dietary
      habits, physical activity, sleeping habits), anthropometric data (height, weight, waist
      circumference, body composition), and clinic-phenotypical parameters (blood pressure,
      medication, adverse effects, disease prevalence). Biological sample collection will include
      blood, urine, saliva and feces. Biochemical and blood cells parameters will be measured
      (blood cell count, glucose, lipid and hepatic profiles).
    

Intervention name(s): Nutritional intervention; Control
Intervention type(s): Other; Other
Intervention description(s): A nutritional intervention program aimed to reduce UPF consumption. Nutritional intervention will not modify basal caloric intake but will record energy intake along the intervention. Nutritional counseling will be based on nutritional educational material such as encouraged and discouraged food items, recipes, menus and food shopping lists based on unprocessed or minimally processed foods.
Total intervention will last 6 months for both groups. During the intervention phase, a monthly interview with nutritionist/dietitian is scheduled. Face-to-face interviews will be carried out in months 2 and 4. Phone interviews will be carried out in months 1, 3 and 5. In the baseline and final visits (months 0 and 6) a sample and data collection will be performed.; General counseling to adhere to a healthy Mediterranean diet
Other intervention name(s): Reduction of UPF consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled, randomized, parallel groups intervention
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Epigenetics; Methylation; Clinical trial; Causal inference; Non-communicable diseases; Precision nutrition; Ultra-processed food; NOVA; Obesity