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Clinical Trials/NCT03467503
NCT03467503
Completed
N/A

Healthy Diet for Healthy Moms and Babies

University of Nevada, Las Vegas1 site in 1 country34 target enrollmentMay 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
University of Nevada, Las Vegas
Enrollment
34
Locations
1
Primary Endpoint
Gestational weight gain
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
August 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arpita Basu

Associate Professor

University of Nevada, Las Vegas

Eligibility Criteria

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)

Study Sites (1)

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