Healthy Diet for Healthy Moms and Babies

Obesity Clinical Trial

Official title:

Healthy Diet for Healthy Moms and Babies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467503
• Other study ID #: 1155039
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2020
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Obesity
• Pregnancy, High Risk

Intervention

Dietary Supplement:
• Blueberry + soluble fiber
Dietary frozen blueberries and soluble fiber for 20 weeks

Locations

Country	Name	City	State
United States	University of Nevada at Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal metabolomics	Maternal serum NMR metabolites	20 weeks
Primary	Gestational weight gain	Maternal weight gain in lbs	20 weeks
Primary	Gestational glycemia	Maternal blood glucose and HbA1c as measures of glycemia	20 weeks
Primary	Maternal serum lipids	Conventional total, LDL-cholesterol and their particle size to describe lipid profiles	20 weeks
Primary	Maternal inflammation	C-reactive protein as a stable biomarker of inflammation	20 weeks
Secondary	Maternal biomarkers of atherosclerosis	Serum cytokines measured as interleukins and adipokines	20 weeks
Secondary	Maternal dietary intakes	Maternal intakes of energy intake and nutrients	20 weeks