Diet TherapyGENDIETNCT06661330
Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters
An observational study of Diet Therapy and Mediterranean Diet, run by San Raffaele Telematic University at 1 site in Italy.
Trial summary
This study investigates the gender-specific effects of diet and physical activity on metabolic parameters in a cohort of adults. The study involved a 6-month intervention based on a Mediterranean-style diet and regular physical activity, with the primary objective of assessing changes in body composition, fasting… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Therapy, Mediterranean Diet, Body Composition Changes
- What is being tested?
- Behavioral Treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2024to 1 Oct 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study includes 200 adults from a metabolic health clinic in Rome, Italy, participating in a 6-month Mediterranean diet and physical activity intervention.
Who may be able to join
- Adults aged 18 years and older.
- Able to follow a Mediterranean diet and participate in physical activity.
- Provide informed consent.
Who cannot join
- Pregnant women.
- Individuals with severe chronic diseases.
- Participants with alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department for the Promotion of Human Science and Quality of Life San Raffaele Open University
Rome, 00166
About this study
This study investigates the gender-specific effects of diet and physical activity on metabolic parameters in a cohort of adults. The study involved a 6-month intervention based on a Mediterranean-style diet and regular physical activity, with the primary objective of assessing changes in body composition, fasting glucose, lipid profiles, and liver enzymes. Participants were stratified by gender to evaluate whether men and women exhibit different metabolic responses to the intervention. The results aim to provide insights into personalized nutritional recommendations based on gender differences.
Read the detailed description
The study was conducted to explore gender differences in metabolic responses to a Mediterranean-style diet combined with a structured physical activity regimen. The study population included 2,509 participants recruited from a metabolic health clinic in Rome, Italy. Participants followed a 6-month hypocaloric diet, with macronutrient distribution of 16% protein, 25% fats, and 59% carbohydrates. The diet emphasized plant-based foods, with limited red meat consumption and regular intake of fish and poultry. Alongside the dietary intervention, participants were instructed to perform moderate physical activity, including aerobic exercises for 50 minutes, three times a week.
- Being tested
- Behavioral Treatment
- Keywords
- Metabolic parameters, Mediterranean diet, Physical activity, Body composition, Lipid profiles, Gender differences
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentOther
Participants followed a 6-month hypocaloric Mediterranean-style diet, reducing energy intake by approximately 600 kcal/day. The diet emphasized fruits, vegetables, whole grains, and fish, while limiting red meat and processed foods. Additionally, participants were required to perform moderate physical activity, including 50 minutes of aerobic exercise, 3 times a wee
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Intervention Group | This group consists of 200 adults who participated in a 6-month Mediterranean diet intervention combined with regular physical activity. The intervention focused on reducing energy intake by approximately 600 kcal/day while emphasizing plant-based foods, fish, and poultry. Participants' metabolic parameters, including body composition, fasting glucose, lipid profiles, and liver enzymes, were assessed at baseline and after 6 months. Receives: Other: Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Composition (Fat Mass and Lean Mass)
The primary outcome is the change in body composition, specifically fat mass and lean mass, after a 6-month Mediterranean diet intervention combined with regular physical activity.
Measured: Baseline and 6 months
Secondary outcomes (4)
Change in Fasting Glucose
The secondary outcome includes changes in fasting glucose measured at baseline and after the 6-month intervention.
Measured: Baseline and 6 months
Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)
The secondary outcome includes changes in lipid profiles (HDL, LDL, total cholesterol, and triglycerides) measured at baseline and after the 6-month intervention.
Measured: Baseline and 6 months
Change in Creatinine Levels
The secondary outcome includes changes in creatinine levels measured at baseline and after the 6-month intervention.
Measured: Baseline and 6 months
Change in Liver Enzymes (AST, ALT)
The secondary outcome includes changes in liver enzymes (AST, ALT) measured at baseline and after the 6-month intervention.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start2 Jan 2024
- Primary completion31 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diet TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Raffaele Telematic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Lombardo, San Raffaele Telematic University
- Investigators
- Massimiliano Caprio, PhD, Study director, Department for the Promotion of Human Science and Quality of Life San Raffaele Open University, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661330
- Sponsor's protocol ID
- Gender_Diet_2024
- Acronym
- GENDIET
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The de-identified individual participant data (IPD) will be made available to researchers upon reasonable request. Data will be shared securely for the purpose of secondary research.
Publications
Manzano-Carrasco S, Felipe JL, Sanchez-Sanchez J, Hernandez-Martin A, Clavel I, Gallardo L, Garcia-Unanue J. Relationship between Adherence to the Mediterranean Diet and Body Composition with Physical Fitness Parameters in a Young Active Population. Int J Environ Res Public Health. 2020 May 11;17(9):3337. doi: 10.3390/ijerph17093337.
PubMed 32403376Barrea L, Verde L, Suarez R, Frias-Toral E, Vasquez CA, Colao A, Savastano S, Muscogiuri G. Sex-differences in Mediterranean diet: a key piece to explain sex-related cardiovascular risk in obesity? A cross-sectional study. J Transl Med. 2024 Jan 10;22(1):44. doi: 10.1186/s12967-023-04814-z.
PubMed 38200498Gorini S, Camajani E, Cava E, Feraco A, Armani A, Amoah I, Filardi T, Wu X, Strollo R, Caprio M, Padua E, Lombardo M. Gender differences in eating habits and sports preferences across age groups: a cross-sectional study. J Transl Med. 2025 Mar 12;23(1):312. doi: 10.1186/s12967-025-06311-x.
PubMed 40075461Gorini S, Camajani E, Feraco A, Armani A, Karav S, Filardi T, Aulisa G, Cava E, Strollo R, Padua E, Caprio M, Lombardo M. Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters. Nutrients. 2025 Jan 20;17(2):354. doi: 10.3390/nu17020354.
PubMed 39861484
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters
- ClinicalTrials.gov ID
- NCT06661330
- Acronym / sponsor ID
- GENDIET / Gender_Diet_2024
- Keywords
- Metabolic parameters, Mediterranean diet, Physical activity, Body composition, Lipid profiles, Gender differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- San Raffaele Telematic UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 28 Oct 2024 (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 study investigates the gender-specific effects of diet and physical activity on metabolic parameters in a cohort of adults. The study involved a 6-month intervention based on a Mediterranean-style diet and regular physical activity, with the primary objective of assessing changes in body composition, fasting glucose, lipid profiles, and liver enzymes. Participants were stratified by gender to evaluate whether men and women exhibit different metabolic responses to the intervention. The results aim to provide insights into personalized nutritional recommendations based on gender differences.
Detailed description
The study was conducted to explore gender differences in metabolic responses to a Mediterranean-style diet combined with a structured physical activity regimen. The study population included 2,509 participants recruited from a metabolic health clinic in Rome, Italy. Participants followed a 6-month hypocaloric diet, with macronutrient distribution of 16% protein, 25% fats, and 59% carbohydrates. The diet emphasized plant-based foods, with limited red meat consumption and regular intake of fish and poultry. Alongside the dietary intervention, participants were instructed to perform moderate physical activity, including aerobic exercises for 50 minutes, three times a week.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Intervention Group | – | Other: Behavioral TreatmentThis group consists of 200 adults who participated in a 6-month Mediterranean diet intervention combined with regular physical activity. The intervention focused on reducing energy intake by approximately 600 kcal/day while emphasizing plant-based foods, fish, and poultry. Participants' metabolic parameters, including body composition, fasting glucose, lipid profiles, and liver enzymes, were assessed at baseline and after 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes 200 adults from a metabolic health clinic in Rome, Italy, participating in a 6-month Mediterranean diet and physical activity intervention.
Key inclusion criteria (3 listed)
- Adults aged 18 years and older.
- Able to follow a Mediterranean diet and participate in physical activity.
- Provide informed consent.
Key exclusion criteria (3 listed)
- Pregnant women.
- Individuals with severe chronic diseases.
- Participants with alcohol or substance abuse.
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 |
|---|---|---|
| Behavioral TreatmentParticipants followed a 6-month hypocaloric Mediterranean-style diet, reducing energy intake by approximately 600 kcal/day. The diet emphasized fruits, vegetables, whole grains, and fish, while limiting red meat and processed foods. Additionally, participants were required to perform moderate physical activity, including 50 minutes of aerobic exercise, 3 times a wee | Other | Mediterranean Diet Intervention Group |
Primary outcome
Change in Body Composition (Fat Mass and Lean Mass)
Time frame: Baseline and 6 months
The primary outcome is the change in body composition, specifically fat mass and lean mass, after a 6-month Mediterranean diet intervention combined with regular physical activity.
4 secondary outcomes
Change in Fasting Glucose
Time frame: Baseline and 6 months
Change in Lipid Profiles (HDL, LDL, Total Cholesterol, Triglycerides)
Time frame: Baseline and 6 months
Change in Creatinine Levels
Time frame: Baseline and 6 months
Change in Liver Enzymes (AST, ALT)
Time frame: Baseline and 6 months
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 28 Oct 2024.
- Background: PubMed 32403376Manzano-Carrasco S, Felipe JL, Sanchez-Sanchez J, Hernandez-Martin A, Clavel I, Gallardo L, Garcia-Unanue J. Relationship between Adherence to the Mediterranean Diet and Body Composition with Physical Fitness Parameters in a Young Active Population. Int J Environ Res Public Health. 2020 May 11;17(9):3337. doi: 10.3390/ijerph17093337.
- Background: PubMed 38200498Barrea L, Verde L, Suarez R, Frias-Toral E, Vasquez CA, Colao A, Savastano S, Muscogiuri G. Sex-differences in Mediterranean diet: a key piece to explain sex-related cardiovascular risk in obesity? A cross-sectional study. J Transl Med. 2024 Jan 10;22(1):44. doi: 10.1186/s12967-023-04814-z.
- Derived from this study: PubMed 40075461Gorini S, Camajani E, Cava E, Feraco A, Armani A, Amoah I, Filardi T, Wu X, Strollo R, Caprio M, Padua E, Lombardo M. Gender differences in eating habits and sports preferences across age groups: a cross-sectional study. J Transl Med. 2025 Mar 12;23(1):312. doi: 10.1186/s12967-025-06311-x.
- Derived from this study: PubMed 39861484Gorini S, Camajani E, Feraco A, Armani A, Karav S, Filardi T, Aulisa G, Cava E, Strollo R, Padua E, Caprio M, Lombardo M. Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters. Nutrients. 2025 Jan 20;17(2):354. doi: 10.3390/nu17020354.
- Individual participant dataSharing planned: Undecided. The de-identified individual participant data (IPD) will be made available to researchers upon reasonable request. Data will be shared securely for the purpose of secondary research.
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Healthy Volunteers
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.
Massimiliano Caprio, PhD study director
Department for the Promotion of Human Science and Quality of Life San Raffaele Open University, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Therapy and Mediterranean Diet, run by San Raffaele Telematic University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 28 Oct 2024. 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 Italy. 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?
Change in Body Composition (Fat Mass and Lean Mass) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661330, which also lists 4 linked publications.
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 28 Oct 2024.