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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03467503
Other study ID # 1155039
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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