An interventional study of Nutritional intervention and Control in Obesity and Overweight, sponsored by IMDEA Food. Completed at 1 site in Spain. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by IMDEA Food · Not applicable, Interventional, and Prevention
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).
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).
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 33 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Exclusion Criteria:
Participants in the control group will be provided with nutritional guidelines to follow a healthy diet based on a Mediterranean diet.
Other: Control
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.
Also known as: Reduction of UPF consumption
General counseling to adhere to a healthy Mediterranean diet
UPF
Ultra-processed food consumption
Time frame: 6 months
Weight
Weight change (Kg)
Time frame: 6 months
BMI
Change in body mass index (Kg/m2)
Time frame: 6 months
Obesity
Percentage of participants who reverse obesity condition (BMI \< 30 Kg/m2)
Time frame: 6 months
Body composition
Change in % of fat mass
Time frame: 6 months
DNA methylation
Reversibility of DNA methylation marks
Time frame: 12 months
Glucose
Change in fastin glucose levels (mg/dL)
Time frame: 9 months
Glycated haemoglobin
Change in fastin glycated haemoglobin levels (%)
Time frame: 9 months
Triglycerides
Change in fasting triglycerides levels (mg/dL)
Time frame: 9 months
LDL-cholesterol
Change in fasting LDL-cholesterol levels (mg/dL)
Time frame: 9 months
HDL-cholesterol
Change in fasting HDL-cholesterol levels (mg/dL)
Time frame: 9 months
Liver profile
Change in HSI liver function index
Time frame: 9 months
Microbiota
Changein microbiota diversity
Time frame: 24 months
Plan to share: No — Informed consent does not allow to make data publicly available. Nevertheless, data could be share upon request to the investigators.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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