Healthy Diet for Healthy Moms and Babies

Not Applicable

Completed

• Conditions: Gestational Diabetes; Obesity; Pregnancy, High Risk
• Interventions: Dietary Supplement: Blueberry + soluble fiber

• Registration Number: NCT03467503
• Lead Sponsor: University of Nevada, Las Vegas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-16
• Study Start: 2018-05-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Intervention	Blueberry + soluble fiber	Participants were given dietary blueberries (2 cups) and soluble fiber (12g). They also received nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	20 weeks	Maternal weight gain in lbs
Maternal inflammation	20 weeks	C-reactive protein as a stable biomarker of inflammation
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

Secondary Outcome Measures

Name	Time	Method
Maternal dietary intakes	20 weeks	Maternal intakes of energy intake and nutrients
Maternal biomarkers of atherosclerosis	20 weeks	Serum cytokines measured as interleukins and adipokines

Trial Locations

Locations (1)

University of Nevada at Las Vegas; 🇺🇸 Las Vegas, Nevada, United States