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. (PREDIP2)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Terminated; Phase 4

Conditions: Gestational Diabetes; Oxidative Stress

Treatments: Other: placebo; Behavioral: diet; Dietary Supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins

Study type: Interventional

Funder types: Other

Identifiers

NCT05393843

PRE.D.I.P.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: diet

Dietary Supplement: omega-3 fatty acids, anthocyanins and alpha-cyclodextrins

placebo

Placebo Comparator group

Description:

patients receiving * diet * placebo (sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins)

Treatment:

Other: placebo

Behavioral: diet