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

NCT05319327 | Completed

• 1 other identifier: IMD: PI-048
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Overweight

Keywords

Epigenetics; Methylation; Clinical trial; Causal inference; Non-communicable diseases; Precision nutrition; Ultra-processed food; NOVA; Obesity

Outcome Measures

Primary Outcomes (1)

• UPF

  Ultra-processed food consumption

  6 months

Secondary Outcomes (4)

• Weight

  6 months

• BMI

  6 months

• Obesity

  6 months

• Body composition

  6 months

Other Outcomes (8)

• DNA methylation

  12 months

• Glucose

  9 months

• Glycated haemoglobin

  9 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Control

Intervention group

EXPERIMENTAL

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

Interventions

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.

Also known as: Reduction of UPF consumption

Intervention group

Control OTHER

General counseling to adhere to a healthy Mediterranean diet

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

IMDEA Food

Madrid, 28049, Spain

Location

Related Links

• Research team profile
• Research team profile

MeSH Terms

Conditions

Obesity; Overweight; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• José M Ordovás, PhD

  Fundación IMDEA Alimentación

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Controlled, randomized, parallel groups intervention

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 8, 2022
• Study Start: June 6, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)