PregnancyPREGPOLYNCT07656532
Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy
A study testing Natural Non-Alkalized Cocoa and Polyphenol-Rich Dietary Counseling in people with Pregnancy and Gestational Diabetes Mellitus (GDM), run by University of Salamanca at 1 site in Spain.
Trial summary
This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Diabetes Mellitus (GDM), Preeclampsia
- What is being tested?
- Natural Non-Alkalized Cocoa and Polyphenol-Rich Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 18 years or older.
- Singleton pregnancy.
- Gestational age between 8 and 11 weeks at enrollment.
- Receiving prenatal care within the Salamanca Health Area.
- Able to understand the study information and provide written informed consent.
- No clinical restrictions that would contraindicate dietary modifications.
Who cannot join
- Medical or obstetric conditions that contraindicate dietary modifications.
- Active metabolic, renal, or hepatic disease.
- Severe hyperemesis gravidarum or gastrointestinal disorders limiting food intake.
- Allergy or intolerance to cocoa.
- Habitual high cocoa or chocolate consumption (>30 g/day).
- Multiple pregnancy.
- Severe obstetric complications diagnosed before enrollment.
- Inability to comply with study procedures, attend follow-up visits, or communication barriers that could interfere with participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital de Salamanca
Salamanca, SALAMANCA, 37007
Ana García Albarrán, RN, Midwife, 923291100, annagarcialbarran@usal.es
About this study
Official title: Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy
This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes.
Pregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role.
Read more
Pregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations.
The intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes.
The aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.
- Conditions
- Pregnancy, Gestational Diabetes Mellitus (GDM), Preeclampsia, Hypertension, Pregnancy-Induced, Oxidative Stress, Endothelial Dysfunction
- Being tested
- Natural Non-Alkalized Cocoa, Polyphenol-Rich Dietary Counseling
- Keywords
- Mediterranean diet, Polyphenols, Cocoa supplementation, Oxidative stress, Endothelial function, Randomized controlled trial
- Medical subject headings
- Diabetes, Gestational, Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Non-Alkalized CocoaDietary supplement
Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.
Polyphenol-Rich Dietary CounselingBehavioural
Structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a daily dietary intervention consisting of 10 g of natural non-alkalized cocoa and structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables, in addition to general Mediterranean diet recommendations. The intervention will last 12 weeks during pregnancy. Receives: Dietary Supplement: Natural Non-Alkalized Cocoa; Behavioral: Polyphenol-Rich Dietary Counseling |
| Control Group | Active comparator | Participants will receive standard dietary advice based on general healthy eating and Mediterranean diet recommendations during pregnancy, without specific supplementation or structured dietary intervention. Receives: Behavioral: Polyphenol-Rich Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum sVCAM-1 concentration
Change in serum soluble vascular cell adhesion molecule-1 (sVCAM-1) levels from baseline to 24-28 weeks of gestation, measured in [ng/mL].
Measured: Baseline, 24-28 weeks, and 32-36 weeks of gestation
Change in serum sFlt-1/PlGF ratio
Change in the soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1/PlGF) ratio from baseline to 24-28 weeks and 32-36 weeks of gestation.
Measured: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
Change in serum nitric oxide concentration
Change in serum nitric oxide (NO) concentration from baseline to 24-28 weeks and 32-36 weeks of gestation, measured in [pg/mL].
Measured: Baseline, 24-28 weeks, and 32-36 weeks of gestation.
Change in serum IL-6 concentration
Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in [pg/mL].
Measured: Baseline, 24-28 weeks, and 32-36 weeks of gestation
Secondary outcomes (1)
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Change in adherence to the Mediterranean diet measured using the Mediterranean Diet Adherence Screener (MEDAS). Scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.
Measured: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving a polyphenol-rich dietary intervention or a control group receiving standard dietary advice. Both groups will be followed in parallel throughout pregnancy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana García Albarrán, University of Salamanca
- Investigators
- Ana García Albarrán, RN, Midwife, Principal investigator, University of SalamancaSusana González Manzano, PharmD, Study director, University of SalamancaMaría Begoña Ayuda Durán, PharmD, Study director, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656532
- Sponsor's protocol ID
- USAL-CT-2026-001
- Acronym
- PREGPOLY
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, there is no finalized plan for sharing individual participant data (IPD). Due to the sensitive nature of maternal and neonatal health data and the presence of biological and clinical information, data sharing will be considered in accordance with institutional ethics requirements, participant consent, and applicable data protection regulations. Any potential future sharing of de-identified data will be determined after study completion and in line with publication and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy
- ClinicalTrials.gov ID
- NCT07656532
- Acronym / sponsor ID
- PREGPOLY / USAL-CT-2026-001
- Conditions
- Pregnancy, Gestational Diabetes Mellitus (GDM), Preeclampsia, Hypertension, Pregnancy-Induced, Oxidative Stress, Endothelial Dysfunction
- Keywords
- Mediterranean diet, Polyphenols, Cocoa supplementation, Oxidative stress, Endothelial function, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 18 Jun 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 is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes.
Pregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role.
Pregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations.
The intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes.
The aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving a polyphenol-rich dietary intervention or a control group receiving standard dietary advice. Both groups will be followed in parallel throughout pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Natural Non-Alkalized Cocoa, Behavioral: Polyphenol-Rich Dietary CounselingParticipants will receive a daily dietary intervention consisting of 10 g of natural non-alkalized cocoa and structured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables, in addition to general Mediterranean diet recommendations. The intervention will last 12 weeks during pregnancy. |
| Control Group | Active comparator | Behavioral: Polyphenol-Rich Dietary CounselingParticipants will receive standard dietary advice based on general healthy eating and Mediterranean diet recommendations during pregnancy, without specific supplementation or structured dietary intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women aged 18 years or older.
- Singleton pregnancy.
- Gestational age between 8 and 11 weeks at enrollment.
- Receiving prenatal care within the Salamanca Health Area.
- Able to understand the study information and provide written informed consent.
Key exclusion criteria (8 listed)
- Medical or obstetric conditions that contraindicate dietary modifications.
- Active metabolic, renal, or hepatic disease.
- Severe hyperemesis gravidarum or gastrointestinal disorders limiting food intake.
- Allergy or intolerance to cocoa.
- Habitual high cocoa or chocolate consumption (>30 g/day).
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 |
|---|---|---|
| Natural Non-Alkalized CocoaStructured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet. | Dietary supplement | Intervention Group |
| Polyphenol-Rich Dietary CounselingStructured nutritional counseling aimed at achieving at least five daily servings of fruits and vegetables and improving adherence to the Mediterranean diet. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in serum sVCAM-1 concentration
Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation
Change in serum soluble vascular cell adhesion molecule-1 (sVCAM-1) levels from baseline to 24-28 weeks of gestation, measured in [ng/mL].
Change in serum sFlt-1/PlGF ratio
Time frame: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
Change in the soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1/PlGF) ratio from baseline to 24-28 weeks and 32-36 weeks of gestation.
Change in serum nitric oxide concentration
Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation.
Change in serum nitric oxide (NO) concentration from baseline to 24-28 weeks and 32-36 weeks of gestation, measured in [pg/mL].
Change in serum IL-6 concentration
Time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation
Change in circulating interleukin-6 levels between baseline and follow-up assessments, measured in [pg/mL].
1 secondary outcome
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Time frame: Baseline, 24-28 weeks of gestation, and 32-36 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. At present, there is no finalized plan for sharing individual participant data (IPD). Due to the sensitive nature of maternal and neonatal health data and the presence of biological and clinical information, data sharing will be considered in accordance with institutional ethics requirements, participant consent, and applicable data protection regulations. Any potential future sharing of de-identified data will be determined after study completion and in line with publication and regulatory requirements.
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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.
Ana García Albarrán, RN, Midwife principal investigator
University of Salamanca
Susana González Manzano, PharmD study director
University of Salamanca
María Begoña Ayuda Durán, PharmD study director
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Non-Alkalized Cocoa and Polyphenol-Rich Dietary Counseling in people with Pregnancy and Gestational Diabetes Mellitus (GDM), run by University of Salamanca 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?
The sponsor lists 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana García Albarrán, RN, Midwife (923291100, annagarcialbarran@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum sVCAM-1 concentration (time frame: Baseline, 24-28 weeks, and 32-36 weeks of gestation). The study lists 4 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 18 Jun 2026.