NCT05393843

Prevention of Maternal and Fetal Metabolic Complications With Diet and Nutraceutical Supplementation in Pregnant Women Affected by Gestational Diabetes: a Randomized, Double-blind Placebo Controlled Trial.

Prevention of Maternal and Fetal Metabolic Complications With Polyphenols and Omega-3 Fatty Acids Supplementation in Pregnant Women Affected by Gestational Diabetes on Diet Therapy: a Randomized, Double-blind Placebo Controlled Trial.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes. Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.

Detailed description

Randomized, Double-blind trial Aims: evaluation of the metabolic effect on patients affected by gestational diabetes of anti-inflammatory, anti-oxidant nutraceutical supplementation with omega-3 fatty acids, anthocyanins and alpha-cyclodextrins for 12 weeks associated with appropriate nutritional coaching versus nutritional coaching and placebo. All women receive a personalized diet by a nutrition expert educator and should monitor capillary blood glucose levels. Patients receive twice-weekly antenatal testing, including ultrasonography for fetal growth and well-being maternal weight body fat mass distribution evaluation using skinfold caliper, dietary counselling. Blood and urine samples are drawn from all patients at recruitment and at the last study visit.

Conditions

• Gestational Diabetes
• Oxidative Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	omega-3 fatty acids, anthocyanins and alpha-cyclodextrins	administration for 12 weeks
BEHAVIORAL	diet	12 weeks of personalized diet according to the Mediterranean standard diet referrals, the Healthy Eating Plate recommendations of Harvard University School of Public Health, and the reference intake levels of nutrients and energy for the Italian population (LARN) for pregnant women
OTHER	placebo	sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins; administration for 12 weeks

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2022-05-26
• Last updated: 2022-05-26

Locations

1 site across 1 country: Italy