Overweight/obesity in general population Other
Conditions
Interventions
If the volunteer passes the eligibility criteria, they will be enrolled into the study and randomly allocated (2:1, using a computer based program online) to one of the 2 intervention arms (personalis
PDA or general dietary advice
GDA). The study will last 28 weeks (16 weeks wait for analysis to be completed and 12 weeks of intervention and will recruit 105 volunteers (70 on the PDA arm and 35 on the GDA arm). All study visits
Sponsors
Universitat de València
CIBEROBN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old 2. Body Mass Index (BMI) greater than or equal to 25 kg/m² (Asian descent individuals BMI greater than or equal to 23 kg/m²) 3. Waist circumference greater than or equal to 102 cm in males and greater than or equal to 88 cm in females (Asian descent individuals: greater than or equal to 90 cm in males greater than or equal to 80 cm in females) 4. Ability to consent on their own and understand what the study involves
Exclusion criteria
Exclusion criteria: 1. Individuals with type 2 diabetes, chronic gastrointestinal conditions such as Crohn’s disease, irritable bowel syndrome, celiac disease or ulcerative colitis, acute infectious diseases, cancer, cardiovascular diseases, and autoimmune conditions 2. Individuals who have been on antibiotics in the past three months and/or during the study duration 3. Pregnant or breastfeeding women 4. Currently participating in other clinical trials or who have participated in clinical trials in the past 3 months 5. Individuals who are undergoing medical interventions during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dietary intake assessed using the Healthy Eating Index Score at baseline and at the end of the study (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma risk factors for non-communicable diseases, assessed by calculating plasma glucose, HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline and the end of the study (12 weeks) 2. Blood pressure levels measured using a blood pressure monitor at baseline and the end of the study (12 weeks) 3. Asociation between genetic factors (SNPs at the genome-wide-level and genetic risk scores) and epigenetic factors (DNA-methylation) and the primary and the other secondary outcomes 5. Changes in microRNA and RNA expresion associated with the relevant parameters after the intervention | — |
Countries
Spain
Contacts
Public ContactDolores Corella
Outcome results
None listed