A Pragmatic Randomized Controlled Trial of Health Impact of Pistachios on Women With Gestational Diabetes Mellitus
Gestational Diabetes Mellitus in Pregnancy
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy
Eligibility Criteria
Inclusion Criteria: Chinese women at the age of 20-45 years, with Han ethnicity and singleton pregnancies Women who are at 20-30 weeks' singleton gestation and have the first onset of hyperglycemia which fulfills at least one of the following criteria: fasting glucose ≥5.1 mmol/L, 1 h glucose ≥10 mmol/L or 2 h glucose ≥8.5 mmol/L during the 2 h 75 g OGTT. Pregestational BMI greater than 24 kg/m2. Willing to comply with the research requirements Exclusion Criteria: Gastrointestinal malabsorption and chronic diseases that alter nutrient metabolism Allergy or intolerance to pistachios Pre-existing diabetes, insulin resistance, impaired fasting glucose or impaired glucose tolerance Pregnancy with more than one fetus Current or planned corticosteroid therapy Current or planned beta adrenergic therapy Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Stand care control group (CG)
Intervention group (IG)
According to the Chinese nutritional guidelines for GDM women, the energy intake of 1500-1800 kcal/d will be recommended for the included participants, who all have the pregestational BMI≥24 kg/m2. Standard care and a balanced diet will be recommended to the women in CG incorporating nuts intake of less than 2.5 oz per week.
The participants in the IG will be offered the otherwise same diet as their counterparts in the CG, except for the extra intake of pistachios of 1.5 oz thrice per week.