Healthy Diet for Healthy Moms and Babies

NCT03467503 — Not applicable, Completed, 34 participants, University of Nevada, Las Vegas

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Registry	NCT03467503
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	34 (Actual)
Sponsor	University of Nevada, Las Vegas (Other)
Conditions	Gestational Diabetes, Obesity, Pregnancy, High Risk
Interventions	Blueberry + soluble fiber (Dietary supplement)
Dates	start 2018-05-01, primary completion 2020-08-31, completion 2020-08-31, first posted 2018-03-16, last updated 2020-11-19
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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	Dietary Supplement: Blueberry + soluble fiber	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.

Blueberry + soluble fiber (Dietary supplement): Dietary frozen blueberries and soluble fiber for 20 weeks

+Outcome measures

Primary outcomes

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

Secondary outcomes

Maternal biomarkers of atherosclerosis [20 weeks]: Serum cytokines measured as interleukins and adipokines
Maternal dietary intakes [20 weeks]: Maternal intakes of energy intake and nutrients

Other outcomes

Maternal metabolomics [20 weeks]: Maternal serum NMR metabolites

+Eligibility

Sex: Female, ages: 19 Years to 40 Years, accepts 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

+Locations (1)

Facility	City	Country	Status
University of Nevada at Las Vegas	Las Vegas, Nevada	United States

+Publications

Results publication: 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 33693835

+Investigators

Arpita Basu, PhD, Principal investigator, University of Nevada at Las Vegas