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OpenTrials
Completed

NCT Number: NCT07450066

Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes

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.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Diet

Other

A six-month intervention consisting of lifestyle counseling aimed at promoting adherence to a standard Mediterranean diet and providing phenotype-tailored physical activity recommendations.

Primary outcomes

  1. Body Mass Index

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    BMI will be calculated from body weight and height using the formula: BMI = weight (kg) / height (m)²

  2. Body Fat Percentage

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Body fat (%) will be assessed by bioelectrical impedance analysis (BIA)

Secondary outcomes

  1. Body Weight

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Body weight will be measured in kilograms (kg) using a calibrated scale

  2. Waist Circumference

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Waist Circumference will be measured in centimeters (cm) using a non-elastic tape measure

  3. Hip Circumferenc

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Hip Circumference will be measured in centimeters (cm) using a non-elastic tape measure

  4. CUN-BAE

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    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)

  5. Waist-to-hip ratio

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Waist-to-hip ratio will be calculated as: waist circumference (cm) / hip circumference (cm).

  6. Waist-to-height ratio

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Waist-to-height ratio will be calculated as: waist circumference (cm) / height (cm).

  7. Plasma Leptin

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma leptin levels will be measured in ng/mL using enzyme-linked immunosorbent assay (ELISA).

  8. Plasma Adiponectin

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma Adiponectin levels will be measured in µg/mL using ELISA.

  9. Adiponectin-Leptin Ratio

    Time frame: Baseline, Month 6 (end) of intervention

    The adiponectin/leptin ratio will be calculated as: adiponectin (µg/mL) / leptin (ng/mL).

  10. Plasma Tumor necrosis factor alpha (TNF-α)

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma TNF-α will be measured in pg/mL using ELISA.

  11. Plasma Interleukin-6 (IL-6)

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma IL-6 measured in pg/mL using ELISA.

  12. Plasma Triglycerides

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma Triglycerides measured in mg/dL using enzymatic colorimetric commercial kit.

  13. Plasma Total Cholesterol

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma Total Cholesterol measured in mg/dL using enzymatic colorimetric commercial kit.

  14. Plasma High-Density Lipoprotein (HDL) cholesterol

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma HDL cholesterol measured in mg/dL using enzymatic colorimetric commercial kit after dextran precipitation.

  15. Plasma Low-Density Lipoprotein (LDL) cholesterol

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma LDL cholesterol levels (mg/dL) will be calculated using the Friedewald formula: LDL-C = Total Cholesterol - [HDL Cholesterol + (Triglycerides / 5)].

  16. Non-HDL Cholesterol

    Time frame: Baseline, Month 6 (end) of intervention

    Non-HDL cholesterol will be calculated as: Total Cholesterol (mg/dL) - HDL cholesterol (mg/dL).

  17. Fasting glucose

    Time frame: Baseline, Month 6 (end) of intervention

    Fasting glucose will be measured in mg/dL using a glucometer

  18. Fasting insulin

    Time frame: Baseline, Month 6 (end) of intervention

    Fasting insulin will be measured in mU/L using ELISA.

  19. Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline, Month 6 (end) of intervention

    HOMA-IR = [fasting insulin (mU/L) × fasting glucose (mg/dL)] / 405

  20. Insulin sensitivity will be estimated using the Quantitative Insulin Sensitivity Check Index (QUICKI)

    Time frame: Baseline, Month 6 (end) of intervention

    QUICKI = 1 / [log(fasting insulin µU/mL) + log(fasting glucose mg/dL)]

  21. Plasma Irisin

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma Irisin measured using ELISA.

  22. Plasma Fibroblast growth factor 21 (FGF-21)

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma FGF-21 measured using ELISA.

  23. Plasma Uric Acid

    Time frame: Baseline, Month 6 (end) of intervention

    Plasma Uric Acid measured in mg/dL using enzymatic colorimetric commercial kit.

  24. Dietary intake assessment

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Dietary intake will be evaluated using a 65-item Food Frequency Questionnaire (FFQ) for dietary pattern analysis.

  25. Physical Activity Level

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Physical activity will be estimated using the International Physical Activity Questionnaire (IPAQ).

  26. Adherence to the Mediterranean diet

    Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention

    Adherence to the Mediterranean diet will be evaluated using the MEDAS questionnaire.

  27. Plasma Gamma-glutamyltransferase (γ-glutamyltransferase, GGT)

    Time frame: Baseline, Month 6 (end) of intervention

    GGT activity determined in plasma using a commercial enzymatic assay kit for the quantitative measurement of γ-glutamyl transferase.

  28. Plasma alanine transaminase (ALT)

    Time frame: Baseline, Month 6 (end) of intervention

    ALT activity determined in plasma using a commercial enzymatic assay kit for the quantitative measurement of alanine aminotransferase.

Sponsors and collaborators

Lead sponsor

University of the Balearic Islands

Other

Registry information

Official study title

Estudio en Humanos Para la identificación de Biomarcadores de Actividad física Moderada y Sedentarismo y su Posible relación Con Determinantes genéticos e Indicadores Del Estado de Salud metabólica

Acronym: MAR-GEN

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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