Healthy Diet for Healthy Moms and Babies

NCT ID: NCT03467503

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-08-31

Brief Summary

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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

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Conditions

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Gestational Diabetes Obesity Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Prenatal Care/Nutrition Education

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Blueberry + soluble fiber

Intervention Type DIETARY_SUPPLEMENT

Dietary frozen blueberries and soluble fiber for 20 weeks

Interventions

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Blueberry + soluble fiber

Dietary frozen blueberries and soluble fiber for 20 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

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Arpita Basu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arpita Basu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada at Las Vegas

Locations

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University of Nevada at Las Vegas

Las Vegas, Nevada, United States

Site Status

Countries

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United States

References

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Basu A, Feng D, Planinic P, Ebersole JL, Lyons TJ, Alexander JM. Dietary Blueberry and Soluble Fiber Supplementation Reduces Risk of Gestational Diabetes in Women with Obesity in a Randomized Controlled Trial. J Nutr. 2021 May 11;151(5):1128-1138. doi: 10.1093/jn/nxaa435.

Reference Type DERIVED
PMID: 33693835 (View on PubMed)

Other Identifiers

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1155039

Identifier Type: -

Identifier Source: org_study_id