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Healthy Diet for Healthy Moms and Babies

Primary Purpose

Gestational Diabetes, Obesity, Pregnancy, High Risk

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry + soluble fiber
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nevada at Las Vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Prenatal Care/Nutrition Education

Dietary Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2018
Last Updated
November 17, 2020
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT03467503
Brief Title
Healthy Diet for Healthy Moms and Babies
Official Title
Healthy Diet for Healthy Moms and Babies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Obesity, Pregnancy, High Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prenatal Care/Nutrition Education
Arm Type
No Intervention
Arm Description
Participants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.
Arm Title
Dietary Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry + soluble fiber
Intervention Description
Dietary frozen blueberries and soluble fiber for 20 weeks
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Maternal weight gain in lbs
Time Frame
20 weeks
Title
Gestational glycemia
Description
Maternal blood glucose and HbA1c as measures of glycemia
Time Frame
20 weeks
Title
Maternal serum lipids
Description
Conventional total, LDL-cholesterol and their particle size to describe lipid profiles
Time Frame
20 weeks
Title
Maternal inflammation
Description
C-reactive protein as a stable biomarker of inflammation
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Maternal biomarkers of atherosclerosis
Description
Serum cytokines measured as interleukins and adipokines
Time Frame
20 weeks
Title
Maternal dietary intakes
Description
Maternal intakes of energy intake and nutrients
Time Frame
20 weeks
Other Pre-specified Outcome Measures:
Title
Maternal metabolomics
Description
Maternal serum NMR metabolites
Time Frame
20 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnancy study
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arpita Basu, PhD
Organizational Affiliation
University of Nevada at Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada at Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33693835
Citation
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.
Results Reference
derived

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Healthy Diet for Healthy Moms and Babies

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