Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes (NCT07450066) | Clinical Trial Compass
CompletedNot Applicable
Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes
Spain150 participantsStarted 2020-10-27
Plain-language summary
This clinical trial aims to recruit a core cohort of adults with normal weight, overweight, and obesity, but without other metabolic alterations, to undergo a six-month nutritional intervention. The main objective is to compare a genotype- and phenotype-based nutrition approach with a traditional nutrition plan adjusted only to phenotype. To evaluate the effectiveness of each type of intervention, anthropometric measurements and nutritional assessments will be collected at baseline, three months, and six months. In addition, plasma samples will be obtained to analyze clinical and non-clinical biomarkers, providing a more comprehensive evaluation of health status at baseline and after six months of intervention.
Who can participate
Age range
25 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria: Men and women aged between 25 and 55 years; volunteers who sign the informed consent forms for sample collection and for participation in the study, after having read the information sheet of the research project; absence of known disease.
Exclusion criteria: participants younger than 25 years and older than 55 years; physically or legally incapacitated persons; pregnant or breastfeeding women; presence of blood-borne infectious diseases (HIV/AIDS, hepatitis, etc.); presence of diseases associated with a risk of complications during blood extraction (coagulation disorders, heart failure, etc.); individuals with diabetes, hypertension, grade II or higher obesity (BMI ≥35), or those receiving chronic medication (excluding contraceptives).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Mass Index
Timeframe: Baseline, Month 3 of intervention, Month 6 (end) of intervention
2
Body Fat Percentage
Timeframe: Baseline, Month 3 of intervention, Month 6 (end) of intervention