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outbreak of covid pandemic that caused problems with nutritional coaching in person.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Active Comparator | patients receiving
|
|
| placebo | Placebo Comparator | patients receiving
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 fatty acids, anthocyanins and alpha-cyclodextrins | Dietary Supplement | administration for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| capillary blood glucose level | 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; | 12 weeks |
| plasmatic glycated haemoglobin | change in plasmatic glycated haemoglobin | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| therapy for diabetes | percentage of patients requiring pharmacological treatment for gestational diabetes such as insulin or methformin | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
pregnant patients
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| Name | Affiliation | Role |
|---|---|---|
| Enrico Ferrazzi, Professor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
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randomized, double-blind
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| diet | Behavioral | 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 |
|
| placebo | Other | sunflower oil as placebo for Omega3 fatty acids; isomaltulosio as placebo for Anthocyanins and Alpha-cyclodextrins; administration for 12 weeks |
|
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D000872 | Anthocyanins |
| D047391 | alpha-Cyclodextrins |
| D004032 | Diet |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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