Healthy Diet for Healthy Moms and Babies

Sponsor

University of Nevada, Las Vegas (Other)

Overall Status

Completed

CT.gov ID

NCT03467503

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Obesity Pregnancy, High Risk	Dietary Supplement: Blueberry + soluble fiber	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

Healthy Diet for Healthy Moms and Babies

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Prenatal Care/Nutrition Education Participants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.
Experimental: Dietary Intervention 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.	Dietary Supplement: Blueberry + soluble fiber Dietary frozen blueberries and soluble fiber for 20 weeks

Arm

Intervention/Treatment

No Intervention: Prenatal Care/Nutrition Education

Participants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.

Experimental: Dietary Intervention

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.

Dietary Supplement: Blueberry + soluble fiber

Dietary frozen blueberries and soluble fiber for 20 weeks

Outcome Measures

Primary Outcome Measures

Gestational weight gain [20 weeks]
Maternal weight gain in lbs
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
Maternal inflammation [20 weeks]
C-reactive protein as a stable biomarker of inflammation

Secondary Outcome Measures

Maternal biomarkers of atherosclerosis [20 weeks]
Serum cytokines measured as interleukins and adipokines
Maternal dietary intakes [20 weeks]
Maternal intakes of energy intake and nutrients

Other Outcome Measures

Maternal metabolomics [20 weeks]
Maternal serum NMR metabolites

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

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
Anemia
Allergic to berries and fiber
Vegetarian food habits or special diets
Not proficient in English and/or unable to provide consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada at Las Vegas	Las Vegas	Nevada	United States	89154

Sponsors and Collaborators

University of Nevada, Las Vegas

Investigators

Principal Investigator: Arpita Basu, PhD, University of Nevada at Las Vegas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arpita Basu, Associate Professor, University of Nevada, Las Vegas

ClinicalTrials.gov Identifier:

NCT03467503

Other Study ID Numbers:

1155039

First Posted:

Mar 16, 2018

Last Update Posted:

Nov 19, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes, Gestational

Study Results

No Results Posted as of Nov 19, 2020