Cardiovascular DiseasesNCT07443787
Mediterranean Diet and Physical Activity in Breast Cancer Patients Under Hormone Therapy
A study testing Mediterranean diet and Physical activity promotion in people with Cardiovascular Diseases, run by MOHAMEDI Ilhem Sarra Manel at 1 site in Algeria.
Trial summary
This study aims to evaluate body weight status, lifestyle patterns, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the effects of a structured nutritional intervention based on the Mediterranean diet combined with physical activity promotion. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Mediterranean diet and Physical activity promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAlgeria
- Study dates
- 2 May 2022to 24 Jun 2025
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed hormone receptor-positive breast cancer
- Breast cancer survivors receiving adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) for ≥3 months
- No recurrence or second primary malignancy
- Ability to perform moderate-intensity physical activity
- Consecutively recruited during routine surveillance visits
Who cannot join
- Incomplete or discontinued hormone therapy
- Concurrent ovarian suppression
- Use of lipid-lowering medications
- Severe uncontrolled comorbidities (e.g., diabetes, cardiac, or hepatic disease)
- Cognitive or physical impairments preventing informed consent or participation
- Restrictive dietary regimens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Mediterranean-type Diet and Promotion of Physical Activity on Nutritional Status and Cardiometabolic Risk in Breast Cancer Patients Undergoing Adjuvant Hormone Therapy
This study aims to evaluate body weight status, lifestyle patterns, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the effects of a structured nutritional intervention based on the Mediterranean diet combined with physical activity promotion.
A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Oran, Algeria. Participants include women receiving tamoxifen or aromatase inhibitors. Baseline assessments include anthropometric measurements (body weight, body mass index, waist and hip circumferences), socioeconomic characteristics, and lifestyle evaluation.
Read more
Dietary intake is assessed using 24-hour dietary recalls and 3-day food records. Total energy intake, macronutrient and micronutrient composition, dietary habits, meal distribution, and adherence to the Mediterranean diet (MEDAS score) are evaluated. Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are also determined.
Cardiometabolic risk is assessed through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic ratios.
A structured educational program promoting adherence to the Mediterranean diet and increased physical activity is implemented. Anthropometric, dietary, lifestyle, and cardiometabolic parameters are monitored over time to evaluate changes associated with the intervention.
Read the detailed description
The objective of this interventional study is to evaluate body weight status, lifestyle characteristics, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the impact of a nutritional intervention based on the Mediterranean diet combined with physical activity promotion.
A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Aïn El Turc, Oran, Algeria. Participants are classified according to the type of endocrine treatment received, including tamoxifen or aromatase inhibitors.
Baseline evaluation includes anthropometric measurements such as body weight, body mass index, waist circumference, and hip circumference. Socioeconomic characteristics and lifestyle habits are documented.
Dietary assessment is conducted using 24-hour dietary recalls and 3-day food records. Nutritional analysis includes total energy intake, macronutrient and micronutrient composition, dietary quality, meal distribution, and adherence to the Mediterranean diet assessed using the MEDAS score. Food group consumption patterns and dietary behaviors are also evaluated.
Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are determined using standardized assessment methods.
Cardiometabolic risk profile is evaluated through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic indices.
Following baseline assessment, participants receive a structured educational program promoting adherence to the Mediterranean dietary pattern and regular physical activity. Follow-up assessments are conducted to monitor changes in anthropometric parameters, dietary habits, lifestyle behaviors, and cardiometabolic markers over time.
- Conditions
- Cardiovascular Diseases
- Being tested
- Mediterranean diet, Physical activity promotion
- Keywords
- Dietary assessment, Mediterranean diet, Cardiovascular risk, Breast cancer survivors, physical activity, Endocrine therapy
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
Dietary counseling and guidance to promote adherence to the Mediterranean diet over a 3-month period.
Physical activity promotionBehavioural
Counseling and structured recommendations to increase regular physical activity over a 3-month period.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention group | Other | Breast cancer patients receiving a Mediterranean diet intervention combined with physical activity promotion for 3 months, with assessments conducted at baseline and after the intervention. Receives: Behavioral: Mediterranean diet; Behavioral: Physical activity promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference
Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention.
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in body mass index (BMI)
Measured: Time Frame: Baseline and 3 months
Change in lipid profile
Description: Changes in total cholesterol, LDL-C, HDL-C and triglycerides
Measured: Baseline and 3 months
Change in systolic and diastolic blood pressure
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start2 May 2022
- Primary completion26 Feb 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- MOHAMEDI Ilhem Sarra Manel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oran 1
- Responsible party
- Sponsor-investigator, MOHAMEDI Ilhem Sarra Manel, University of Oran 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443787
- Sponsor's protocol ID
- UOran1-2022-Nutrition-01
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Only aggregated results, such as means and standard deviations of measured outcomes, will be published to evaluate the impact of the Mediterranean diet and physical activity promotion. All data will remain confidential and no personal identifiers will be made publicly available
Publications
Mohamedi ISM, Ghomari-Boukhatem H, Moussaoui I, Raiah M, Bouchenak M. Lifestyle factors and cardiometabolic risk in breast cancer patients under different hormones therapy. Med J Nutrition Metab. 2025; 18(3):194-203. doi:10.1177/1973798X251353349.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mediterranean-type Diet and Promotion of Physical Activity on Nutritional Status and Cardiometabolic Risk in Breast Cancer Patients Undergoing Adjuvant Hormone Therapy
- ClinicalTrials.gov ID
- NCT07443787
- Acronym / sponsor ID
- UOran1-2022-Nutrition-01
- Conditions
- Cardiovascular Diseases
- Keywords
- Dietary assessment, Mediterranean diet, Cardiovascular risk, Breast cancer survivors, physical activity, Endocrine therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- MOHAMEDI Ilhem Sarra ManelUniversity, hospital or other
- Collaborators
- University of Oran 1
- Study start
- 2 May 2022 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 2 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 study aims to evaluate body weight status, lifestyle patterns, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the effects of a structured nutritional intervention based on the Mediterranean diet combined with physical activity promotion.
A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Oran, Algeria. Participants include women receiving tamoxifen or aromatase inhibitors. Baseline assessments include anthropometric measurements (body weight, body mass index, waist and hip circumferences), socioeconomic characteristics, and lifestyle evaluation.
Dietary intake is assessed using 24-hour dietary recalls and 3-day food records. Total energy intake, macronutrient and micronutrient composition, dietary habits, meal distribution, and adherence to the Mediterranean diet (MEDAS score) are evaluated. Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are also determined.
Cardiometabolic risk is assessed through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic ratios.
A structured educational program promoting adherence to the Mediterranean diet and increased physical activity is implemented. Anthropometric, dietary, lifestyle, and cardiometabolic parameters are monitored over time to evaluate changes associated with the intervention.
Detailed description
The objective of this interventional study is to evaluate body weight status, lifestyle characteristics, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the impact of a nutritional intervention based on the Mediterranean diet combined with physical activity promotion.
A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Aïn El Turc, Oran, Algeria. Participants are classified according to the type of endocrine treatment received, including tamoxifen or aromatase inhibitors.
Baseline evaluation includes anthropometric measurements such as body weight, body mass index, waist circumference, and hip circumference. Socioeconomic characteristics and lifestyle habits are documented.
Dietary assessment is conducted using 24-hour dietary recalls and 3-day food records. Nutritional analysis includes total energy intake, macronutrient and micronutrient composition, dietary quality, meal distribution, and adherence to the Mediterranean diet assessed using the MEDAS score. Food group consumption patterns and dietary behaviors are also evaluated.
Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are determined using standardized assessment methods.
Cardiometabolic risk profile is evaluated through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic indices.
Following baseline assessment, participants receive a structured educational program promoting adherence to the Mediterranean dietary pattern and regular physical activity. Follow-up assessments are conducted to monitor changes in anthropometric parameters, dietary habits, lifestyle behaviors, and cardiometabolic markers over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention group | Other | Behavioral: Mediterranean diet, Behavioral: Physical activity promotionBreast cancer patients receiving a Mediterranean diet intervention combined with physical activity promotion for 3 months, with assessments conducted at baseline and after the intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed hormone receptor-positive breast cancer
- Breast cancer survivors receiving adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) for ≥3 months
- No recurrence or second primary malignancy
- Ability to perform moderate-intensity physical activity
- Consecutively recruited during routine surveillance visits
Key exclusion criteria (6 listed)
- Incomplete or discontinued hormone therapy
- Concurrent ovarian suppression
- Use of lipid-lowering medications
- Severe uncontrolled comorbidities (e.g., diabetes, cardiac, or hepatic disease)
- Cognitive or physical impairments preventing informed consent or participation
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 |
|---|---|---|
| Mediterranean dietDietary counseling and guidance to promote adherence to the Mediterranean diet over a 3-month period. | Behavioural | Lifestyle intervention group |
| Physical activity promotionCounseling and structured recommendations to increase regular physical activity over a 3-month period. | Behavioural | Lifestyle intervention group |
Primary outcome
Change in waist circumference
Time frame: Baseline and 3 months
Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention.
3 secondary outcomes
Change in body mass index (BMI)
Time frame: Time Frame: Baseline and 3 months
Change in lipid profile
Time frame: Baseline and 3 months
Change in systolic and diastolic blood pressure
Time frame: Baseline and 3 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 2 Mar 2026.
- BackgroundMohamedi ISM, Ghomari-Boukhatem H, Moussaoui I, Raiah M, Bouchenak M. Lifestyle factors and cardiometabolic risk in breast cancer patients under different hormones therapy. Med J Nutrition Metab. 2025; 18(3):194-203. doi:10.1177/1973798X251353349.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Only aggregated results, such as means and standard deviations of measured outcomes, will be published to evaluate the impact of the Mediterranean diet and physical activity promotion. All data will remain confidential and no personal identifiers will be made publicly available
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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 Mediterranean diet and Physical activity promotion in people with Cardiovascular Diseases, run by MOHAMEDI Ilhem Sarra Manel at 1 site in Algeria.
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 5 inclusion and 6 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 2 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 Algeria. 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 waist circumference (time frame: Baseline and 3 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 NCT07443787, which also lists 1 linked publication.
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 2 Mar 2026.