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NCT Number: NCT05319327

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

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).

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Key information

Conditions

Obesity Body Weight Disease Attributes Noncommunicable Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMDEA Food

Madrid, 28049, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional intervention

Other

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

Control

Other

General counseling to adhere to a healthy Mediterranean diet

Primary outcomes

  1. UPF

    Time frame: 6 months

    Ultra-processed food consumption

Secondary outcomes

  1. Weight

    Time frame: 6 months

    Weight change (Kg)

  2. BMI

    Time frame: 6 months

    Change in body mass index (Kg/m2)

  3. Obesity

    Time frame: 6 months

    Percentage of participants who reverse obesity condition (BMI < 30 Kg/m2)

  4. Body composition

    Time frame: 6 months

    Change in % of fat mass

Other outcomes

  1. DNA methylation

    Time frame: 12 months

    Reversibility of DNA methylation marks

  2. Glucose

    Time frame: 9 months

    Change in fastin glucose levels (mg/dL)

  3. Glycated haemoglobin

    Time frame: 9 months

    Change in fastin glycated haemoglobin levels (%)

  4. Triglycerides

    Time frame: 9 months

    Change in fasting triglycerides levels (mg/dL)

  5. LDL-cholesterol

    Time frame: 9 months

    Change in fasting LDL-cholesterol levels (mg/dL)

  6. HDL-cholesterol

    Time frame: 9 months

    Change in fasting HDL-cholesterol levels (mg/dL)

  7. Liver profile

    Time frame: 9 months

    Change in HSI liver function index

  8. Microbiota

    Time frame: 24 months

    Changein microbiota diversity

Sponsors and collaborators

Lead sponsor

IMDEA Food

Other

Registry information

Acronym: METHYL-UP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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