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.

Phase 4

Terminated

• Conditions: Gestational Diabetes; Oxidative Stress
• Interventions: Dietary Supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins; Behavioral: diet; Other: placebo

• Registration Number: NCT05393843
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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.

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-05-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• patients between 24 and 28 weeks of gestation with positive result to an Oral Glucose Tolerance Test with 75 gr glucose performed after 24 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) recommendations (at least one of the following criteria: baseline glycemia ≥ 92 mg/dl, 1-h glycemia ≥ 180 mg/dl, 2-h glycemia ≥ 153 mg/dl)
• maternal age ≥ 18 years.

Exclusion Criteria

• multiple pregnancies
• fetal malformation
• maternal diseases (type 1 and type 2 diabetes, hypothyroidism and hyperthyroidism, immunological disorders)
• abnormal blood glucose values before 24 weeks of gestation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	omega-3 fatty acids, anthocyanins and alpha-cyclodextrins	patients receiving * diet * Omega-3 fatty acids (EnerZona Omega3Rx®, Enervit, Italia), at a daily dosage of 2.4 gr at breakfast. * Anthocyanins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 108 mg divided into three equal intakes at breakfast, lunch and dinner. * Alpha-cyclodextrins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 15 gr divided into three equal intakes at breakfast, lunch and din-ner
intervention	diet	patients receiving * diet * Omega-3 fatty acids (EnerZona Omega3Rx®, Enervit, Italia), at a daily dosage of 2.4 gr at breakfast. * Anthocyanins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 108 mg divided into three equal intakes at breakfast, lunch and dinner. * Alpha-cyclodextrins (EnerZona Maqui Response Buste®, Enervit, Italia) at a total daily dosage of 15 gr divided into three equal intakes at breakfast, lunch and din-ner
placebo	diet	patients receiving * diet * placebo (sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins)
placebo	placebo	patients receiving * diet * placebo (sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins)

Primary Outcome Measures

Name	Time	Method
capillary blood glucose level	12 weeks	percentage of patients with median capillary blood glucose values 10 mg/dl below the target (if the fetal abdominal circunference is below 75° percentile according to gestational age: basal level 95 mg/dl, 2-h post prandial level 120 mg/dl; if the fetal abdominal circunference is above 75° percentile according to gestational age: basal level 90 mg/dl, 2-h post prandial level 110 mg/dl;
plasmatic glycated haemoglobin	12 weeks	change in plasmatic glycated haemoglobin

Secondary Outcome Measures

Name	Time	Method
therapy for diabetes	12 weeks	percentage of patients requiring pharmacological treatment for gestational diabetes such as insulin or methformin

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy