Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healthy Diet for Healthy Moms and Babies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467503
Recruitment Status : Completed
First Posted : March 16, 2018
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Arpita Basu, University of Nevada, Las Vegas

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: 20 weeks ]
    Maternal weight gain in lbs

  2. Gestational glycemia [ Time Frame: 20 weeks ]
    Maternal blood glucose and HbA1c as measures of glycemia

  3. Maternal serum lipids [ Time Frame: 20 weeks ]
    Conventional total, LDL-cholesterol and their particle size to describe lipid profiles

  4. Maternal inflammation [ Time Frame: 20 weeks ]
    C-reactive protein as a stable biomarker of inflammation


Secondary Outcome Measures :
  1. Maternal biomarkers of atherosclerosis [ Time Frame: 20 weeks ]
    Serum cytokines measured as interleukins and adipokines

  2. Maternal dietary intakes [ Time Frame: 20 weeks ]
    Maternal intakes of energy intake and nutrients


Other Outcome Measures:
  1. Maternal metabolomics [ Time Frame: 20 weeks ]
    Maternal serum NMR metabolites


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy study
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467503


Locations
Layout table for location information
United States, Nevada
University of Nevada at Las Vegas
Las Vegas, Nevada, United States, 89154
Sponsors and Collaborators
University of Nevada, Las Vegas
Investigators
Layout table for investigator information
Principal Investigator: Arpita Basu, PhD University of Nevada at Las Vegas
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Arpita Basu, Associate Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT03467503    
Other Study ID Numbers: 1155039
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases