Gestational Diabetes, Obesity, Pregnancy, High Risk
Conditions
Brief summary
The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the development of gestational diabetes, maternal glucose and lipid control and inflammation in obese pregnant women at risk of developing diabetes. With the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly increasing and the goal of this research is to identify optimal dietary strategies that can reverse this condition or control the rise in blood glucose among those with already developed diabetes.
Interventions
DIETARY_SUPPLEMENTBlueberry + soluble fiber
Dietary frozen blueberries and soluble fiber for 20 weeks
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI \> or = 30, \<20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes
Exclusion criteria
* • Twin or multiple pregnancy * Chronic pre-pregnancy conditions (CHD, cancer, diabetes) * Gastrointestinal conditions * Anemia * Allergic to berries and fiber * Vegetarian food habits or special diets * Not proficient in English and/or unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational weight gain | 20 weeks | Maternal weight gain in lbs |
| Gestational glycemia | 20 weeks | Maternal blood glucose and HbA1c as measures of glycemia |
| Maternal serum lipids | 20 weeks | Conventional total, LDL-cholesterol and their particle size to describe lipid profiles |
| Maternal inflammation | 20 weeks | C-reactive protein as a stable biomarker of inflammation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal biomarkers of atherosclerosis | 20 weeks | Serum cytokines measured as interleukins and adipokines |
| Maternal dietary intakes | 20 weeks | Maternal intakes of energy intake and nutrients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal metabolomics | 20 weeks | Maternal serum NMR metabolites |
Countries
United States
Outcome results
None listed