ObesityMETHYL-UPNCT05319327
Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study
A study testing Nutritional intervention in people with Obesity and Overweight, run by IMDEA Food at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men/women
- 18-50 years old
- BMI 25-40 Kg/m2
- UPF consumption > 35% of total intake in g/day
Who cannot join
- Pregnancy
- Menopause
- IMC <25 Kg/m2 or > 40 Kg/m2
- Excessive alcohol consumption
- Prevalent cardiovascular, renal, lung, pancreatic or liver disease
- Type 1 diabetes
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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).
Read the 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).
- Conditions
- Obesity, Overweight
- Being tested
- Nutritional intervention, Control
- Keywords
- Epigenetics, Methylation, Clinical trial, Causal inference, Non-communicable diseases, Precision nutrition, Ultra-processed food, NOVA, Obesity
- Medical subject headings
- Obesity, Overweight, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionOther
Also called Reduction of UPF consumption
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.
ControlOther
General counseling to adhere to a healthy Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPF
Ultra-processed food consumption
Measured: 6 months
Secondary outcomes (4)
Weight
Weight change (Kg)
Measured: 6 months
BMI
Change in body mass index (Kg/m2)
Measured: 6 months
Obesity
Percentage of participants who reverse obesity condition (BMI < 30 Kg/m2)
Measured: 6 months
Body composition
Change in % of fat mass
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start6 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, randomized, parallel groups intervention
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidia Daimiel Ruiz, IMDEA Food
- Investigators
- José M Ordovás, PhD, Study director, Fundación IMDEA Alimentación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319327
- Sponsor's protocol ID
- IMD: PI-048
- Acronym
- METHYL-UP
- Status last verified
- Oct 2024
- First submitted
- 21 Mar 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Informed consent does not allow to make data publicly available. Nevertheless, data could be share upon request to the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study
- ClinicalTrials.gov ID
- NCT05319327
- Acronym / sponsor ID
- METHYL-UP / IMD: PI-048
- Conditions
- Obesity, Overweight
- Keywords
- Epigenetics, Methylation, Clinical trial, Causal inference, Non-communicable diseases, Precision nutrition, Ultra-processed food, NOVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Controlled, randomized, parallel groups intervention
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: ControlParticipants in the control group will be provided with nutritional guidelines to follow a healthy diet based on a Mediterranean diet. |
| Intervention group | Experimental | Other: Nutritional interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men/women
- 18-50 years old
- BMI 25-40 Kg/m2
- UPF consumption > 35% of total intake in g/day
Key exclusion criteria (12 listed)
- Pregnancy
- Menopause
- IMC <25 Kg/m2 or > 40 Kg/m2
- Excessive alcohol consumption
- Prevalent cardiovascular, renal, lung, pancreatic or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional interventionAlso: Reduction of UPF consumptionA 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 | Intervention group |
| ControlGeneral counseling to adhere to a healthy Mediterranean diet | Other | Control Group |
Primary outcome
UPF
Time frame: 6 months
Ultra-processed food consumption
4 secondary outcomes
Weight
Time frame: 6 months
BMI
Time frame: 6 months
Obesity
Time frame: 6 months
Body composition
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Research team profileLink provided by the sponsor.
- Research team profileLink provided by the sponsor.
- Individual participant dataSharing planned: No. Informed consent does not allow to make data publicly available. Nevertheless, data could be share upon request to the investigators.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José M Ordovás, PhD study director
Fundación IMDEA Alimentación
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention in people with Obesity and Overweight, run by IMDEA Food at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPF (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.