Effects of pistachios on women with gestational diabetes
A Pragmatic Randomized Controlled Trial of Health Impact of Pistachios on Women
This study tests if eating pistachios three times a week can help improve health for Chinese women with gestational diabetes during their pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05694520 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the health impact of pistachio consumption on women diagnosed with gestational diabetes mellitus (GDM). Participants will consume 1.5 ounces of pistachios three times a week during their pregnancy. The study aims to evaluate whether this dietary intervention can improve health outcomes related to GDM, which has seen a rising prevalence globally. The trial focuses on Chinese women aged 20-45 years who meet specific criteria for GDM.
Who should consider this trial
Good fit: Ideal candidates are Chinese women aged 20-45 years with singleton pregnancies and diagnosed with gestational diabetes.
Not a fit: Patients with pre-existing diabetes, multiple fetuses, or gastrointestinal issues that affect nutrient absorption may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that helps manage gestational diabetes and improve pregnancy outcomes.
How similar studies have performed: Previous studies have indicated that dietary interventions, particularly those involving nuts, can positively impact gestational diabetes outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Rongrong Li
- Email: lirongrong0331@163.com
- Phone: 8601069154095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.