Healthy Diet for Healthy Moms and Babies

November 17, 2020 updated by: Arpita Basu, University of Nevada, Las Vegas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • University of Nevada at Las Vegas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational weight gain
Time Frame: 20 weeks
Maternal weight gain in lbs
20 weeks
Gestational glycemia
Time Frame: 20 weeks
Maternal blood glucose and HbA1c as measures of glycemia
20 weeks
Maternal serum lipids
Time Frame: 20 weeks
Conventional total, LDL-cholesterol and their particle size to describe lipid profiles
20 weeks
Maternal inflammation
Time Frame: 20 weeks
C-reactive protein as a stable biomarker of inflammation
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal biomarkers of atherosclerosis
Time Frame: 20 weeks
Serum cytokines measured as interleukins and adipokines
20 weeks
Maternal dietary intakes
Time Frame: 20 weeks
Maternal intakes of energy intake and nutrients
20 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal metabolomics
Time Frame: 20 weeks
Maternal serum NMR metabolites
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nevada, Las Vegas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

August 31, 2020

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (ACTUAL)

March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1155039

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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