Mediterranean Dietary Intervention on ROS Levels and TAC During Pregnancy

NCT07214402 | Completed

• 1 other identifier: 89/19-07-2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Pregnant Women

Keywords

diet; ROS; TAC; oxidative stress; biomarkers; pregnancy; dietary counselling

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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

  From the time before pregnancy to the end of the first trimester of pregnancy (12-13 weeks of pregnancy)

Study Arms (1)

Intervention on individual dietary counselling about Mediterranean diet

EXPERIMENTAL

Other: dietary counselling

Interventions

dietary counselling OTHER

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

Intervention on individual dietary counselling about Mediterranean diet

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women at the end of the first trimester of pregnancy (12-13 weeks of pregnancy)

Sponsors & Collaborators

• University of Western Macedonia: lead

Study Sites (1)

University of Western Macedonia

Ptolemaida, 50200, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 9, 2025
• Study Start: March 6, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)