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Gestational DiabetesNCT03467503

Healthy Diet for Healthy Moms and Babies

A study testing Blueberry + soluble fiber in people with Gestational Diabetes and Obesity, run by University of Nevada, Las Vegas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Blueberry + soluble fiber
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
1 May 2018to 31 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nevada at Las Vegas

    Las Vegas, Nevada, 89154

Other trials in United States

About this study

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.

Being tested
Blueberry + soluble fiber
Medical subject headings
Diabetes, Gestational, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blueberry + soluble fiberDietary supplement

    Dietary frozen blueberries and soluble fiber for 20 weeks

Study groups in NCT03467503
Study groupRoleWhat they receive
Prenatal Care/Nutrition EducationNo interventionParticipants were given nutrition educational counseling on healthy dietary habits and gestational weight gain as part of standard prenatal care.
Dietary InterventionExperimentalParticipants 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.
Receives: Dietary Supplement: Blueberry + soluble fiber

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational weight gain

    Maternal weight gain in lbs

    Measured: 20 weeks

  2. Gestational glycemia

    Maternal blood glucose and HbA1c as measures of glycemia

    Measured: 20 weeks

  3. Maternal serum lipids

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

    Measured: 20 weeks

  4. Maternal inflammation

    C-reactive protein as a stable biomarker of inflammation

    Measured: 20 weeks

Secondary outcomes (2)

  1. Maternal biomarkers of atherosclerosis

    Serum cytokines measured as interleukins and adipokines

    Measured: 20 weeks

  2. Maternal dietary intakes

    Maternal intakes of energy intake and nutrients

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2018
  2. Study start1 May 2018
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03467503
Sponsor's protocol ID
1155039
Status last verified
Nov 2020
First submitted
9 Mar 2018
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33693835

Questions about this trial

What is this clinical trial studying?

A study testing Blueberry + soluble fiber in people with Gestational Diabetes and Obesity, run by University of Nevada, Las Vegas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain (time frame: 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03467503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.

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