Healthy Pregnant WomenNCT07214402
Mediterranean Dietary Intervention on ROS Levels and TAC During Pregnancy
A study testing dietary counselling in people with Healthy Pregnant Women, run by University of Western Macedonia at 1 site in Greece.
Trial summary
This study focuses on investigating the effects of dietary counseling on antioxidant intakes and how diet can influence reactive oxygen species levels and consequently oxidative stress during pregnancy. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Pregnant Women
- What is being tested?
- dietary counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 6 Mar 2023to 28 Mar 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women at the end of the first trimester of pregnancy (12-13 weeks of pregnancy)
Who cannot join
- Exclusion criteria included hypertension, diabetes, placenta previa, genital tract infections and multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mediterranean Dietary Intervention on Reactive Oxygen Species Levels and Total Antioxidant Capacity During Pregnancy
This study focuses on investigating the effects of dietary counseling on antioxidant intakes and how diet can influence reactive oxygen species levels and consequently oxidative stress during pregnancy. This study aims to evaluate oxidative stress biomarkers in pregnant women following online sessions focused on Mediterranean dietary intervention, compared to a control group receiving no dietary guidance. The findings are intended to support the development of targeted public health strategies to reduce the risk of adverse pregnancy outcomes.
Read the detailed description
At the end of the first trimester of pregnancy (12-13 week of pregnancy), women are randomized into a control group and to intervention group to receive individual dietary counselling. In the intervention group, the dietary counselling about the Mediterranean diet is carried out during 6 online meetings every 15 days and focused on antioxidant nutrients and their intake. They are encouraged to adopt a 12-week antioxidant diet, including increased consumption of antioxidant-rich foods such as ≥5 servings/day vegetables, ≥2 servings/day fruit, ≥8 ½ servings/day wholegrains and 3-4 servings/week lean meat. In the control group, dietary counselling included generic, standard of care guidance about nutrition in pregnancy and is only discussed during a single session. Oxidative stress biomarkers, particularly Reactive Oxygen Species (ROS) and Total Antioxidant Capacity (TAC) levels, are analyzed before and after the study duration in women's serum.
Eight-hour fasting blood samples of all women are collected in evacuated containers with EDTA and without anticoagulant from the cubitus vein, at rest. Samples are centrifuged immediately in a dark room at 500g for 15 min at 4°C. After serum samples are isolated, they are immediately aliquoted and stored at - 80°C until analyzed after specific pretreatments for each assay.
Reactive oxygen species (ROS) are detected in serum using the cell-permeable, ROS-sensitive probe 2',7'-dichlorodihydrofluorescein diacetate (H2DCFDA), which emits fluorescence at 520 nm when oxidized [excitation at 480 nm]. A 0.5 mM stock solution of H2DCFDA in DMSO is used, and the probe is incubated for 30 minutes with human serum samples. ROS levels are assessed at each designated time point. Fluorescence measurements are taken using a Tecan fluorometer with black 96-well microplates. ROS concentrations are quantified in millimolar (mM) units by referencing a standard curve generated using hydrogen peroxide (H2O2) concentrations ranging from 0 to 3 mM.
Trolox equivalent antioxidant capacity methodology is used to evaluate the serum TAC. Antioxidant activity is assayed spectrophotometrically, using a TAC Kit (Total Antioxidant Capacity Colorimetric assay kit, produced by Cayman Chemical Co., Ann Arbor, USA). Antioxidants inhibit the oxidation of 2,2'-azino-bis (3-ethylbenthiazoline)-6-sulphonic acid by the ferryl myoglobin-H2O2 system. Antioxidant concentration is expressed as millimolar Trolox equivalents (mmol/l).
Data are analyzed using IBM SPSS Statistics 19.0. Normality of distribution of data in all groups of pregnant women is determined by Kolmogorov - Smirnov normality test. Descriptive statistics, presented as means ± standard deviations, are performed. An independent samples t-test is conducted to compare the mean baseline levels of ROS between the two groups prior to the intervention, ensuring initial comparability. Baseline non-parametric levels of TAC are compared between the intervention and control groups using the Mann-Whitney U test. The Wilcoxon signed-rank test is used for both variables to compare the two groups after the intervention. Results are considered significant at p < 0.05, with effect sizes (Cohen's d,) reported for clinical relevance.
- Conditions
- Healthy Pregnant Women
- Being tested
- dietary counselling
- Keywords
- diet, ROS, TAC, oxidative stress, biomarkers, pregnancy, dietary counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary counsellingOther
12-week antioxidant diet, including increased consumption of antioxidant-rich foods such as ≥5 servings/day vegetables, ≥2 servings/day fruit, ≥8 ½ servings/day wholegrains and 3-4 servings/week lean meat
| Study group | Role | What they receive |
|---|---|---|
| Intervention on individual dietary counselling about Mediterranean diet | Experimental | Not described Receives: Other: dietary counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Oxygen Species (ROS) levels will be analyzed before and after the dietary counselling intervention in women's serum and will be quantified in millimolar (mM) units
Measured: From enrollment to the end of dietary counselling intervention at 12 weeks
Total antioxidant capacity (TAC) levels will be analyzed before and after the dietary counselling intervention in women's serum and will be expressed as millimolar Trolox equivalents (mmol/l)
Measured: From enrollment to the end of dietary counselling intervention at 12 weeks
Secondary outcomes (1)
Weight (in kilograms) berore pregnancy and at the end of the first trimester, as well as height (in meters) will be combined to report BMI (in kg/m^2) berore pregnancy and at the end of the first trimester
Measured: From the time before pregnancy to the end of the first trimester of pregnancy (12-13 weeks of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start6 Mar 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Pregnant WomenStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Macedonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214402
- Sponsor's protocol ID
- 89/19-07-2022
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2025
- Last updated
- 9 Oct 2025
- 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 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mediterranean Dietary Intervention on Reactive Oxygen Species Levels and Total Antioxidant Capacity During Pregnancy
- ClinicalTrials.gov ID
- NCT07214402
- Acronym / sponsor ID
- 89/19-07-2022
- Conditions
- Healthy Pregnant Women
- Keywords
- diet, ROS, TAC, oxidative stress, biomarkers, pregnancy, dietary counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Western MacedoniaUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 9 Oct 2025 (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 focuses on investigating the effects of dietary counseling on antioxidant intakes and how diet can influence reactive oxygen species levels and consequently oxidative stress during pregnancy. This study aims to evaluate oxidative stress biomarkers in pregnant women following online sessions focused on Mediterranean dietary intervention, compared to a control group receiving no dietary guidance. The findings are intended to support the development of targeted public health strategies to reduce the risk of adverse pregnancy outcomes.
Detailed description
At the end of the first trimester of pregnancy (12-13 week of pregnancy), women are randomized into a control group and to intervention group to receive individual dietary counselling. In the intervention group, the dietary counselling about the Mediterranean diet is carried out during 6 online meetings every 15 days and focused on antioxidant nutrients and their intake. They are encouraged to adopt a 12-week antioxidant diet, including increased consumption of antioxidant-rich foods such as ≥5 servings/day vegetables, ≥2 servings/day fruit, ≥8 ½ servings/day wholegrains and 3-4 servings/week lean meat. In the control group, dietary counselling included generic, standard of care guidance about nutrition in pregnancy and is only discussed during a single session. Oxidative stress biomarkers, particularly Reactive Oxygen Species (ROS) and Total Antioxidant Capacity (TAC) levels, are analyzed before and after the study duration in women's serum.
Eight-hour fasting blood samples of all women are collected in evacuated containers with EDTA and without anticoagulant from the cubitus vein, at rest. Samples are centrifuged immediately in a dark room at 500g for 15 min at 4°C. After serum samples are isolated, they are immediately aliquoted and stored at - 80°C until analyzed after specific pretreatments for each assay.
Reactive oxygen species (ROS) are detected in serum using the cell-permeable, ROS-sensitive probe 2',7'-dichlorodihydrofluorescein diacetate (H2DCFDA), which emits fluorescence at 520 nm when oxidized [excitation at 480 nm]. A 0.5 mM stock solution of H2DCFDA in DMSO is used, and the probe is incubated for 30 minutes with human serum samples. ROS levels are assessed at each designated time point. Fluorescence measurements are taken using a Tecan fluorometer with black 96-well microplates. ROS concentrations are quantified in millimolar (mM) units by referencing a standard curve generated using hydrogen peroxide (H2O2) concentrations ranging from 0 to 3 mM.
Trolox equivalent antioxidant capacity methodology is used to evaluate the serum TAC. Antioxidant activity is assayed spectrophotometrically, using a TAC Kit (Total Antioxidant Capacity Colorimetric assay kit, produced by Cayman Chemical Co., Ann Arbor, USA). Antioxidants inhibit the oxidation of 2,2'-azino-bis (3-ethylbenthiazoline)-6-sulphonic acid by the ferryl myoglobin-H2O2 system. Antioxidant concentration is expressed as millimolar Trolox equivalents (mmol/l).
Data are analyzed using IBM SPSS Statistics 19.0. Normality of distribution of data in all groups of pregnant women is determined by Kolmogorov - Smirnov normality test. Descriptive statistics, presented as means ± standard deviations, are performed. An independent samples t-test is conducted to compare the mean baseline levels of ROS between the two groups prior to the intervention, ensuring initial comparability. Baseline non-parametric levels of TAC are compared between the intervention and control groups using the Mann-Whitney U test. The Wilcoxon signed-rank test is used for both variables to compare the two groups after the intervention. Results are considered significant at p < 0.05, with effect sizes (Cohen's d,) reported for clinical relevance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention on individual dietary counselling about Mediterranean diet | Experimental | Other: dietary counselling |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women at the end of the first trimester of pregnancy (12-13 weeks of pregnancy)
Key exclusion criteria (1 listed)
- Exclusion criteria included hypertension, diabetes, placenta previa, genital tract infections and multiple pregnancies
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 |
|---|---|---|
| dietary counselling12-week antioxidant diet, including increased consumption of antioxidant-rich foods such as ≥5 servings/day vegetables, ≥2 servings/day fruit, ≥8 ½ servings/day wholegrains and 3-4 servings/week lean meat | Other | Intervention on individual dietary counselling about Mediterranean diet |
Primary outcome
Reactive Oxygen Species (ROS) levels will be analyzed before and after the dietary counselling intervention in women's serum and will be quantified in millimolar (mM) units
Time frame: From enrollment to the end of dietary counselling intervention at 12 weeks
Total antioxidant capacity (TAC) levels will be analyzed before and after the dietary counselling intervention in women's serum and will be expressed as millimolar Trolox equivalents (mmol/l)
Time frame: From enrollment to the end of dietary counselling intervention at 12 weeks
1 secondary outcome
Weight (in kilograms) berore pregnancy and at the end of the first trimester, as well as height (in meters) will be combined to report BMI (in kg/m^2) berore pregnancy and at the end of the first trimester
Time frame: From the time before pregnancy to the end of the first trimester of pregnancy (12-13 weeks of pregnancy)
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 9 Oct 2025.
- 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 dietary counselling in people with Healthy Pregnant Women, run by University of Western Macedonia at 1 site in Greece.
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 1 inclusion and 1 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 9 Oct 2025. 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 Greece. 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?
Reactive Oxygen Species (ROS) levels will be analyzed before and after the dietary counselling intervention in women's serum and will be quantified in millimolar (mM) units (time frame: From enrollment to the end of dietary counselling intervention at 12 weeks). 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 9 Oct 2025.