Healthy Diet for Healthy Moms and Babies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Gestational weight gain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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
- •Allergic to berries and fiber
- •Vegetarian food habits or special diets
- •Not proficient in English and/or unable to provide consent
Outcomes
Primary Outcomes
Gestational weight gain
Time Frame: 20 weeks
Maternal weight gain in lbs
Maternal inflammation
Time Frame: 20 weeks
C-reactive protein as a stable biomarker of inflammation
Gestational glycemia
Time Frame: 20 weeks
Maternal blood glucose and HbA1c as measures of glycemia
Maternal serum lipids
Time Frame: 20 weeks
Conventional total, LDL-cholesterol and their particle size to describe lipid profiles
Secondary Outcomes
- Maternal dietary intakes(20 weeks)
- Maternal biomarkers of atherosclerosis(20 weeks)
Investigators
Arpita Basu
Associate Professor
University of Nevada, Las Vegas