Obesity & OverweightMAR-GENNCT07450066
Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes
A study testing Diet in people with Obesity & Overweight, run by University of the Balearic Islands at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2020to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official 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
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.
- Conditions
- Obesity & Overweight
- Being tested
- Diet
- Keywords
- personalized nutrition, nutrigenetics, biomarkers, obesity, overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
A six-month intervention consisting of lifestyle counseling aimed at promoting adherence to a standard Mediterranean diet and providing phenotype-tailored physical activity recommendations.
DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Other: Diet |
| Personalized Nutrition | Experimental | 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. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
BMI will be calculated from body weight and height using the formula: BMI = weight (kg) / height (m)²
Measured: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Body Fat Percentage
Body fat (%) will be assessed by bioelectrical impedance analysis (BIA)
Measured: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Secondary outcomes (28)
Body Weight
Body weight will be measured in kilograms (kg) using a calibrated scale
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, Month 6 (end) of intervention
Plasma Adiponectin
Plasma Adiponectin levels will be measured in µg/mL using ELISA.
Measured: Baseline, Month 6 (end) of intervention
Adiponectin-Leptin Ratio
The adiponectin/leptin ratio will be calculated as: adiponectin (µg/mL) / leptin (ng/mL).
Measured: Baseline, Month 6 (end) of intervention
Plasma Tumor necrosis factor alpha (TNF-α)
Plasma TNF-α will be measured in pg/mL using ELISA.
Measured: Baseline, Month 6 (end) of intervention
Plasma Interleukin-6 (IL-6)
Plasma IL-6 measured in pg/mL using ELISA.
Measured: Baseline, Month 6 (end) of intervention
Plasma Triglycerides
Plasma Triglycerides measured in mg/dL using enzymatic colorimetric commercial kit.
Measured: Baseline, Month 6 (end) of intervention
Plasma Total Cholesterol
Plasma Total Cholesterol measured in mg/dL using enzymatic colorimetric commercial kit.
Measured: 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.
Measured: 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)].
Measured: Baseline, Month 6 (end) of intervention
Non-HDL Cholesterol
Non-HDL cholesterol will be calculated as: Total Cholesterol (mg/dL) - HDL cholesterol (mg/dL).
Measured: Baseline, Month 6 (end) of intervention
Fasting glucose
Fasting glucose will be measured in mg/dL using a glucometer
Measured: Baseline, Month 6 (end) of intervention
Fasting insulin
Fasting insulin will be measured in mU/L using ELISA.
Measured: 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
Measured: 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)]
Measured: Baseline, Month 6 (end) of intervention
Plasma Irisin
Plasma Irisin measured using ELISA.
Measured: Baseline, Month 6 (end) of intervention
Plasma Fibroblast growth factor 21 (FGF-21)
Plasma FGF-21 measured using ELISA.
Measured: Baseline, Month 6 (end) of intervention
Plasma Uric Acid
Plasma Uric Acid measured in mg/dL using enzymatic colorimetric commercial kit.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 6 (end) of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start27 Oct 2020
- Primary completion30 Jan 2024
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450066
- Sponsor's protocol ID
- 3736/18mPI
- Acronym
- MAR-GEN
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07450066
- Acronym / sponsor ID
- MAR-GEN / 3736/18mPI
- Conditions
- Obesity & Overweight
- Keywords
- personalized nutrition, nutrigenetics, biomarkers, obesity, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: DietParticipants 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. |
| Personalized Nutrition | Experimental | Other: DietParticipants 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietA six-month intervention consisting of lifestyle counseling aimed at promoting adherence to a standard Mediterranean diet and providing phenotype-tailored physical activity recommendations. | Other | Control |
| DietA 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. | Other | Personalized Nutrition |
Primary outcome
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
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)
28 secondary outcomes
Body Weight
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Waist Circumference
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Hip Circumferenc
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
CUN-BAE
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Waist-to-hip ratio
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Waist-to-height ratio
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Plasma Leptin
Time frame: Baseline, Month 6 (end) of intervention
Plasma Adiponectin
Time frame: Baseline, Month 6 (end) of intervention
Adiponectin-Leptin Ratio
Time frame: Baseline, Month 6 (end) of intervention
Plasma Tumor necrosis factor alpha (TNF-α)
Time frame: Baseline, Month 6 (end) of intervention
Plasma Interleukin-6 (IL-6)
Time frame: Baseline, Month 6 (end) of intervention
Plasma Triglycerides
Time frame: Baseline, Month 6 (end) of intervention
Plasma Total Cholesterol
Time frame: Baseline, Month 6 (end) of intervention
Plasma High-Density Lipoprotein (HDL) cholesterol
Time frame: Baseline, Month 6 (end) of intervention
Plasma Low-Density Lipoprotein (LDL) cholesterol
Time frame: Baseline, Month 6 (end) of intervention
Non-HDL Cholesterol
Time frame: Baseline, Month 6 (end) of intervention
Fasting glucose
Time frame: Baseline, Month 6 (end) of intervention
Fasting insulin
Time frame: Baseline, Month 6 (end) of intervention
Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, Month 6 (end) of intervention
Insulin sensitivity will be estimated using the Quantitative Insulin Sensitivity Check Index (QUICKI)
Time frame: Baseline, Month 6 (end) of intervention
Plasma Irisin
Time frame: Baseline, Month 6 (end) of intervention
Plasma Fibroblast growth factor 21 (FGF-21)
Time frame: Baseline, Month 6 (end) of intervention
Plasma Uric Acid
Time frame: Baseline, Month 6 (end) of intervention
Dietary intake assessment
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Physical Activity Level
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Adherence to the Mediterranean diet
Time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Plasma Gamma-glutamyltransferase (γ-glutamyltransferase, GGT)
Time frame: Baseline, Month 6 (end) of intervention
Plasma alanine transaminase (ALT)
Time frame: Baseline, Month 6 (end) of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Obesity & Overweight, run by University of the Balearic Islands at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Baseline, Month 3 of intervention, Month 6 (end) of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.