NCT05319327: METHYL-UP

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

Completed NA Last updated 9 October 2024

What this trial tests

NA trial testing Nutritional intervention in Obesity in 33 participants. Completed in 31 December 2022.

Timeline

6 June 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	IMDEA Food
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	33
Start date	6 June 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Spain

Drugs / interventions tested

• Nutritional intervention
• Control

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

IMDEA Food

Who can join

Adults 18 to 50, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.