Clinical trial NCT05319327: Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study
Official title: Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Epigenetics
Methylation
Clinical trial
Causal inference
Non-communicable diseases
Precision nutrition
Ultra-processed food
NOVA
Obesity
Lead sponsor: IMDEA Food
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled, randomized, parallel groups intervention
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Men/women
* 18-50 years old
* BMI 25-40 Kg/m2
* UPF consumption \> 35% of total intake in g/day

Exclusion Criteria:

* Pregnancy
* Menopause
* IMC \<25 Kg/m2 or \> 40 Kg/m2
* Excessive alcohol consumption
* Prevalent cardiovascular, renal, lung, pancreatic or liver disease
* Type 1 diabetes
* Type 2 diabetes with poor glucose control or unstable medication during last 3 months
* Prevalent endocrine disease
* Changes in anti-hypertensive medication during last 3 months
* Insulin, systemic anti-inflammatory, or glucocorticoid medication during last 3 months
* Food allergies or intolerances
* Psychosocial or cultural factors that prevent from following the intervention

Primary outcomes:
measure: UPF
timeFrame: 6 months
Secondary outcomes:
measure: Weight
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: Obesity
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
Other outcomes:
measure: DNA methylation
timeFrame: 12 months
measure: Glucose
timeFrame: 9 months
measure: Glycated haemoglobin
timeFrame: 9 months
measure: Triglycerides
timeFrame: 9 months
measure: LDL-cholesterol
timeFrame: 9 months
measure: HDL-cholesterol
timeFrame: 9 months
measure: Liver profile
timeFrame: 9 months
measure: Microbiota
timeFrame: 24 months
Locations:
city: Madrid
country: Spain
facility: IMDEA Food
Study officials:
affiliation: Fundación IMDEA Alimentación
name: José M Ordovás, PhD
role: STUDY_DIRECTOR
References: