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OpenTrials
Completed

NCT Number: NCT03467503

Healthy Diet for Healthy Moms and Babies

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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Key information

Conditions

Gestational Diabetes Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy, High Risk Signs and Symptoms Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Nevada at Las Vegas

Las Vegas, Nevada, 89154, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blueberry + soluble fiber

Dietary Supplement

Dietary frozen blueberries and soluble fiber for 20 weeks

Primary outcomes

  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 outcomes

  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 outcomes

  1. Maternal metabolomics

    Time frame: 20 weeks

    Maternal serum NMR metabolites

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2018
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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