Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study

Sponsor

IMDEA Alimentación (Other)

Overall Status

Recruiting

CT.gov ID

NCT05319327

Collaborator

(none)

106

Enrollment

Location

Arms

42.8

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Other: Nutritional intervention Other: Control	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Controlled, randomized, parallel groups interventionControlled, randomized, parallel groups intervention

Masking:

Single (Investigator)

Masking Description:

The investigator who will analyze data will be provided with blinded data regarding the groups. Control and intervention groups will be randomly designated as group A and B. Investigator responsible for the analyses of the effect of the intervention on primary outcomes will compared groups A and B in a blinded manner.

Primary Purpose:

Prevention

Official Title:

Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study

Actual Study Start Date :

Jun 6, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Participants in the control group will be provided with nutritional guidelines to follow a healthy diet based on a Mediterranean diet.	Other: Control General counseling to adhere to a healthy Mediterranean diet
Experimental: Intervention group 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 encouraged and discouraged food items, recipes, menus and food shopping lists based on unprocessed or minimally processed foods.	Other: Nutritional intervention 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. Other Names: Reduction of UPF consumption

Arm

Intervention/Treatment

Active Comparator: Control Group

Participants in the control group will be provided with nutritional guidelines to follow a healthy diet based on a Mediterranean diet.

Other: Control

General counseling to adhere to a healthy Mediterranean diet

Experimental: Intervention group

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 encouraged and discouraged food items, recipes, menus and food shopping lists based on unprocessed or minimally processed foods.

Other: Nutritional intervention

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.

Other Names:

Reduction of UPF consumption

Outcome Measures

Primary Outcome Measures

UPF [6 months]
Ultra-processed food consumption

Secondary Outcome Measures

Weight [6 months]
Weight change (Kg)
BMI [6 months]
Change in body mass index (Kg/m2)
Obesity [6 months]
Percentage of participants who reverse obesity condition (BMI < 30 Kg/m2)
Body composition [6 months]
Change in % of fat mass

Other Outcome Measures

DNA methylation [12 months]
Reversibility of DNA methylation marks
Glucose [9 months]
Change in fastin glucose levels (mg/dL)
Glycated haemoglobin [9 months]
Change in fastin glycated haemoglobin levels (%)
Triglycerides [9 months]
Change in fasting triglycerides levels (mg/dL)
LDL-cholesterol [9 months]
Change in fasting LDL-cholesterol levels (mg/dL)
HDL-cholesterol [9 months]
Change in fasting HDL-cholesterol levels (mg/dL)
Liver profile [9 months]
Change in HSI liver function index
Microbiota [24 months]
Changein microbiota diversity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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