Overweight (BMI > 25)NCT07314177
Effects of Three Dietary Strategies on Body Composition and Metabolic Health in Adults With Overweight or Obesity
A study testing Mediterranean Diet, Mediterranean Low-Carbohydrate Diet and High-Protein Diet in people with Overweight (BMI > 25) and Obesity &Amp; Overweight, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
Trial summary
This study aims to compare the effects of three dietary interventions-a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet-on body composition, metabolic health markers, and metabolic syndrome remission in adults with overweight or obesity. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Overweight (BMI > 25), Obesity &Amp; Overweight, Metabolic Syndrome (MetS)
- What is being tested?
- Mediterranean Diet, Mediterranean Low-Carbohydrate Diet and High-Protein Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2024to 25 Jun 2025
- Phase
- Interventional
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-70 years
- Body mass index (BMI) ≥ 25 kg/m² (overweight or obesity)
- Stable body weight (± 2 kg) in the last 3 months prior to screening
- Willingness to follow one of the prescribed dietary interventions for 12 weeks
- Ability to attend scheduled follow-up visits and complete study assessments
- Provided written informed consent prior to study participation
Who cannot join
- Diagnosis of type 1 diabetes, cardiovascular disease, cancer, chronic kidney disease, liver disease, or other serious chronic conditions that could interfere with the intervention
- Pregnancy or breastfeeding
- Current participation in another clinical trial
- History of bariatric surgery or weight-loss program within the past 6 months
- Use of medications known to affect body weight, metabolism, or appetite (e.g., glucocorticoids, weight-loss drugs, antipsychotics)
- Any food allergy or intolerance that would preclude adherence to the assigned diet
- Alcohol or substance abuse
- Any condition or circumstance that, in the opinion of the investigators, would make the participant unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Three Dietary Strategies on Body Composition, Metabolic Markers, and Metabolic Syndrome in Adults With Overweight/Obesity: A Randomized Pilot Trial
This study aims to compare the effects of three dietary interventions-a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet-on body composition, metabolic health markers, and metabolic syndrome remission in adults with overweight or obesity. A total of 45 participants will be randomly assigned to one of the three diets for 12 weeks, with regular follow-up by dietitians. Measurements will include weight, body fat, muscle mass, waist and hip circumference, blood pressure, and blood tests to assess glucose, cholesterol, inflammation, and other metabolic parameters. The findings will help determine whether one dietary pattern is more effective than others in improving short-term health outcomes in this population.
Read the detailed description
Detailed Description:
This randomized, controlled, parallel-group pilot clinical trial will evaluate the effects of three different hypocaloric dietary strategies on body composition, metabolic markers, and metabolic syndrome remission in adults with overweight or obesity.
Background and Rationale Overweight and obesity are highly prevalent in Europe and are associated with an increased risk of metabolic syndrome, cardiovascular disease, type 2 diabetes, and obesity-related cancers. Dietary interventions are a cornerstone in their management, but the optimal macronutrient composition for improving short-term metabolic outcomes remains unclear. This study investigates the comparative impact of a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet over a 12-week period.
Study Design A total of 45 participants aged 18-65 years with a body mass index (BMI) ≥25 kg/m² will be recruited through online advertisements and primary care referrals. After eligibility screening and informed consent, participants will be randomly allocated (1:1:1) to one of the three dietary intervention arms.
Intervention
All diets will be hypocaloric, aiming for a 20-25% reduction in individual energy requirements, and will differ in macronutrient distribution:
Mediterranean diet: 55% carbohydrates, 15% proteins, 30% fats.
Mediterranean low-carbohydrate diet: 40% carbohydrates, 25% proteins, 35% fats.
High-protein diet: 30% carbohydrates, 40% proteins, 30% fats.
Participants will be followed biweekly by qualified dietitians through in-person or phone consultations. They will receive personalized meal plans, nutritional education, and support materials to enhance adherence.
Assessments Anthropometric measures (BMI, fat mass, fat-free mass, waist and hip circumference) will be obtained at baseline and at 12 weeks using standardized protocols and validated equipment. Blood pressure will be measured with a calibrated automated device after a seated rest. Fasting blood samples will be collected in the morning for biochemical analyses, including glucose, HbA1c, insulin, lipid profile, uric acid, iron status, high-sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate, and liver enzymes.
Outcomes The primary outcome is the change in BMI after 12 weeks. Secondary outcomes include changes in body composition, metabolic and inflammatory biomarkers, and the proportion of participants meeting the International Diabetes Federation (IDF) criteria for metabolic syndrome at baseline and post-intervention.
Ethics and Dissemination The study protocol was approved by the Ethics Committee of Aragón (CEICA) (No. 13/2024) and will be conducted in accordance with the Declaration of Helsinki and current regulatory requirements. The findings will be disseminated through peer-reviewed publications and conference presentations.
- Conditions
- Overweight (BMI > 25), Obesity &Amp; Overweight, Metabolic Syndrome (MetS), Cardiometabolic Risk Factors
- Being tested
- Mediterranean Diet, Mediterranean Low-Carbohydrate Diet, High-Protein Diet
- Keywords
- Randomized controlled trial, Mediterranean diet, Low-carbohydrate diet, High-protein diet, Dietary intervention, Metabolic health
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
A traditional Mediterranean diet providing approximately 55% of total energy from carbohydrates, 15% from protein, and 30% from fats. Emphasizes whole grains, vegetables, fruits, legumes, nuts, olive oil, moderate fish and poultry, and limited red meat, processed foods, and added sugars. Energy intake adjusted to achieve a 20-25% caloric deficit.
Mediterranean Low-Carbohydrate DietOther
A Mediterranean-style diet with reduced carbohydrate content (40% of total energy from carbohydrates, 25% from protein, and 35% from fats). Retains core Mediterranean foods while limiting bread, pasta, rice, and other high-carb foods. Energy intake adjusted to achieve a 20-25% caloric deficit.
High-Protein DietOther
A high-protein dietary pattern providing approximately 30% of total energy from carbohydrates, 40% from protein, and 30% from fats. Includes lean meats, poultry, fish, eggs, low-fat dairy, vegetables, nuts, and olive oil, with limited refined carbs and added sugars. Energy intake adjusted to achieve a 20-25% caloric deficit.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Mediterranean Diet | Experimental | Participants assigned to this arm will follow a traditional Mediterranean diet providing approximately 55% of total energy from carbohydrates, 15% from protein, and 30% from fats. The diet emphasizes whole grains, fruits, vegetables, legumes, nuts, olive oil as the primary fat source, moderate fish and poultry intake, and limited consumption of red and processed meats, sweets, and sugary beverages. The prescribed energy intake represents a 20-25% caloric deficit based on individual estimated requirements. Participants receive personalized meal plans, nutritional education, and biweekly follow-up by a registered dietitian. Receives: Other: Mediterranean Diet |
| Arm 2: Mediterranean Low-Carbohydrate Diet | Experimental | Participants assigned to this arm will follow a Mediterranean-style diet with a reduced carbohydrate content, providing approximately 40% of total energy from carbohydrates, 25% from protein, and 35% from fats. The diet retains the core principles of the Mediterranean pattern, emphasizing vegetables, fruits, legumes, nuts, fish, and olive oil, while limiting bread, pasta, rice, and other high-carbohydrate foods. Energy intake is individualized to achieve a 20-25% caloric deficit. Participants receive personalized meal plans, nutritional education, and biweekly follow-up by a registered dietitian. Receives: Other: Mediterranean Low-Carbohydrate Diet |
| Arm 3: High-Protein Diet | Experimental | Participants assigned to this arm will follow a high-protein diet providing approximately 30% of total energy from carbohydrates, 40% from protein, and 30% from fats. Protein sources include lean meats, poultry, fish, eggs, and low-fat dairy products, combined with vegetables, nuts, and healthy fats such as olive oil. Refined carbohydrates and added sugars are limited. Energy intake is individualized to achieve a 20-25% caloric deficit. Participants receive personalized meal plans, nutritional education, and biweekly follow-up by a registered dietitian. Receives: Other: High-Protein Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI, kg/m²) assessed by weight (Tanita MC-780MA bioimpedance scale) and height (Seca stadiometer) from baseline to 12 weeks
BMI will be calculated as weight (kg) divided by height (m²). Weight will be measured without shoes using a Tanita MC-780MA multi-frequency bioelectrical impedance analyzer, and height will be measured using a calibrated Seca wall-mounted stadiometer.
Measured: Baseline and week 12
Secondary outcomes (8)
Change in Fat Mass Percentage (%) assessed by Tanita MC-780MA bioelectrical impedance analyzer from baseline to 12 weeks
Fat mass percentage will be estimated using multi-frequency segmental bioelectrical impedance analysis (Tanita MC-780MA).
Measured: Baseline and week 12
Change in Fat-Free Mass Percentage (%) assessed by Tanita MC-780MA bioelectrical impedance analyzer from baseline to 12 weeks
Fat-free mass percentage will be estimated using multi-frequency segmental bioelectrical impedance analysis (Tanita MC-780MA).
Measured: Baseline and week 12
Change in Metabolic Syndrome Status (yes/no) defined by IDF criteria from baseline to 12 weeks
Metabolic syndrome will be diagnosed according to the International Diabetes Federation (IDF) criteria, requiring ≥3 of the following: elevated waist circumference, elevated triglycerides, reduced HDL cholesterol, elevated blood pressure, or elevated fasting glucose.
Measured: Baseline and week 12
Change in glycated hemoglobin (HbA1c, %) from baseline to 12 weeks
HbA1c levels will be measured in fasting venous blood samples using high-performance liquid chromatography (HPLC), following standardized laboratory procedures.
Measured: Baseline and week 12
Change in serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) from baseline to 12 weeks
Serum lipids will be determined from fasting blood samples analyzed enzymatically in a certified laboratory. Results will be reported in mg/dL for each parameter.
Measured: Baseline and week 12
Change in fasting glucose (mg/dL) from baseline to 12 weeks
Fasting glucose concentration will be measured in venous blood samples collected early in the morning under standardized fasting conditions. Glucose levels will be quantified using validated automated enzymatic assays in a certified clinical laboratory.
Measured: Baseline and week 12
Change in high-sensitivity C-reactive protein (hs-CRP, mg/dL) from baseline to 12 weeks
Serum hs-CRP concentrations will be measured in fasting venous blood samples collected in the morning and analyzed using a standardized high-sensitivity immunoassay in a certified clinical laboratory. Values will be reported in mg/dL.
Measured: Baseline and week 12
Change in serum uric acid (mg/dL) from baseline to 12 weeks
Serum uric acid will be measured by an enzymatic colorimetric method in a certified laboratory. Results will be reported in mg/dL.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start8 Sep 2024
- Primary completion20 Apr 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314177
- Sponsor's protocol ID
- PI24/171
- Other IDs
- CEICA-13/2024-PI24-171
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No