NCT03467503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

March 9, 2018

Last Update Submit

November 17, 2020

Conditions

Gestational DiabetesObesityPregnancy, High Risk

Outcome Measures

Primary Outcomes (4)

  • Gestational weight gain

    Maternal weight gain in lbs

    20 weeks

  • Gestational glycemia

    Maternal blood glucose and HbA1c as measures of glycemia

    20 weeks

  • Maternal serum lipids

    Conventional total, LDL-cholesterol and their particle size to describe lipid profiles

    20 weeks

  • Maternal inflammation

    C-reactive protein as a stable biomarker of inflammation

    20 weeks

Secondary Outcomes (2)

  • Maternal biomarkers of atherosclerosis

    20 weeks

  • Maternal dietary intakes

    20 weeks

Other Outcomes (1)

  • Maternal metabolomics

    20 weeks

Study Arms (2)

Prenatal Care/Nutrition Education

NO INTERVENTION

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

Dietary Intervention

EXPERIMENTAL

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

Interventions

Blueberry + soluble fiberDIETARY_SUPPLEMENT

Dietary frozen blueberries and soluble fiber for 20 weeks

Dietary Intervention

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> or = 30, \<20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada at Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (1)

  • 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.

    PMID: 33693835DERIVED

MeSH Terms

Conditions

Diabetes, GestationalObesity

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arpita Basu, PhD

    University of Nevada at Las Vegas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 16, 2018

Study Start

May 1, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

US(1)