An interventional study of Diet and Diet in Obesity & Overweight, sponsored by University of the Balearic Islands. Completed at 1 site in Spain. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University of the Balearic Islands · Not applicable, Interventional, and Prevention
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 150 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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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).
Participants assigned to this arm (initially comprising 50 individuals) received nutritional counseling to promote adherence to a standard Mediterranean diet, based on general healthy eating guidelines for the Spanish adult population, along with phenotype-tailored recommendations for physical activity.
Other: Diet
Participants in this arm were advised to follow a Mediterranean diet adapted through nutritional and physical activity recommendations tailored to their genetic profile, developed on the basis of a commercial nutrigenetic report.
Other: Diet
A six-month intervention consisting of lifestyle counseling aimed at promoting adherence to a standard Mediterranean diet and providing phenotype-tailored physical activity recommendations.
A 6-month intervention based on the Mediterranean diet with adaptations in nutritional and physical activity guidelines tailored to their genetic profile, according to the report of a commercial nutrigenetic test.
Body Mass Index
BMI will be calculated from body weight and height using the formula: BMI = weight (kg) / height (m)²
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Body Fat Percentage
Body fat (%) will be assessed by bioelectrical impedance analysis (BIA)
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Body Weight
Body weight will be measured in kilograms (kg) using a calibrated scale
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Waist Circumference
Waist Circumference will be measured in centimeters (cm) using a non-elastic tape measure
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Hip Circumferenc
Hip Circumference will be measured in centimeters (cm) using a non-elastic tape measure
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
CUN-BAE
Body fat percentage will be estimated using the Clínica Universidad de Navarra - Body Adiposity Estimator (CUN-BAE) formula: %BF = -44.988 + (0.503 × age) + (10.689 × sex) + (3.172 × BMI) - (0.026 × BMI²) + (0.181 × BMI × sex) - (0.02 × BMI × age) - (0.005 × BMI² × sex) + (0.00021 × BMI² × age) (sex: 0 = male, 1 = female)
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Waist-to-hip ratio
Waist-to-hip ratio will be calculated as: waist circumference (cm) / hip circumference (cm).
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Waist-to-height ratio
Waist-to-height ratio will be calculated as: waist circumference (cm) / height (cm).
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Plasma Leptin
Plasma leptin levels will be measured in ng/mL using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline, Month 6 (end) of intervention
Plasma Adiponectin
Plasma Adiponectin levels will be measured in µg/mL using ELISA.
Time frame: Baseline, Month 6 (end) of intervention
Adiponectin-Leptin Ratio
The adiponectin/leptin ratio will be calculated as: adiponectin (µg/mL) / leptin (ng/mL).
Time frame: Baseline, Month 6 (end) of intervention
Plasma Tumor necrosis factor alpha (TNF-α)
Plasma TNF-α will be measured in pg/mL using ELISA.
Time frame: Baseline, Month 6 (end) of intervention
Plasma Interleukin-6 (IL-6)
Plasma IL-6 measured in pg/mL using ELISA.
Time frame: Baseline, Month 6 (end) of intervention
Plasma Triglycerides
Plasma Triglycerides measured in mg/dL using enzymatic colorimetric commercial kit.
Time frame: Baseline, Month 6 (end) of intervention
Plasma Total Cholesterol
Plasma Total Cholesterol measured in mg/dL using enzymatic colorimetric commercial kit.
Time frame: Baseline, Month 6 (end) of intervention
Plasma High-Density Lipoprotein (HDL) cholesterol
Plasma HDL cholesterol measured in mg/dL using enzymatic colorimetric commercial kit after dextran precipitation.
Time frame: Baseline, Month 6 (end) of intervention
Plasma Low-Density Lipoprotein (LDL) cholesterol
Plasma LDL cholesterol levels (mg/dL) will be calculated using the Friedewald formula: LDL-C = Total Cholesterol - \[HDL Cholesterol + (Triglycerides / 5)\].
Time frame: Baseline, Month 6 (end) of intervention
Non-HDL Cholesterol
Non-HDL cholesterol will be calculated as: Total Cholesterol (mg/dL) - HDL cholesterol (mg/dL).
Time frame: Baseline, Month 6 (end) of intervention
Fasting glucose
Fasting glucose will be measured in mg/dL using a glucometer
Time frame: Baseline, Month 6 (end) of intervention
Fasting insulin
Fasting insulin will be measured in mU/L using ELISA.
Time frame: Baseline, Month 6 (end) of intervention
Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR = \[fasting insulin (mU/L) × fasting glucose (mg/dL)\] / 405
Time frame: Baseline, Month 6 (end) of intervention
Insulin sensitivity will be estimated using the Quantitative Insulin Sensitivity Check Index (QUICKI)
QUICKI = 1 / \[log(fasting insulin µU/mL) + log(fasting glucose mg/dL)\]
Time frame: Baseline, Month 6 (end) of intervention
Plasma Irisin
Plasma Irisin measured using ELISA.
Time frame: Baseline, Month 6 (end) of intervention
Plasma Fibroblast growth factor 21 (FGF-21)
Plasma FGF-21 measured using ELISA.
Time frame: Baseline, Month 6 (end) of intervention
Plasma Uric Acid
Plasma Uric Acid measured in mg/dL using enzymatic colorimetric commercial kit.
Time frame: Baseline, Month 6 (end) of intervention
Dietary intake assessment
Dietary intake will be evaluated using a 65-item Food Frequency Questionnaire (FFQ) for dietary pattern analysis.
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Physical Activity Level
Physical activity will be estimated using the International Physical Activity Questionnaire (IPAQ).
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Adherence to the Mediterranean diet
Adherence to the Mediterranean diet will be evaluated using the MEDAS questionnaire.
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Plasma Gamma-glutamyltransferase (γ-glutamyltransferase, GGT)
GGT activity determined in plasma using a commercial enzymatic assay kit for the quantitative measurement of γ-glutamyl transferase.
Time frame: Baseline, Month 6 (end) of intervention
Plasma alanine transaminase (ALT)
ALT activity determined in plasma using a commercial enzymatic assay kit for the quantitative measurement of alanine aminotransferase.
Time frame: Baseline, Month 6 (end) of intervention
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University of the Balearic Islands