Nutritional Intervention During Gestation and Offspring Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-04-30

Brief Summary

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The purpose of this study is to investigate the potential effects of a modified carbohydrate nutritional product for obese pregnant women to reduce maternal glycemia.

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Detailed Description

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Conditions

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Maternal Glycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nutritional Supplement

One 237 ml oral supplement consumed two times a day; Not commercially available.

Group Type EXPERIMENTAL

Nutritional Supplement

Intervention Type OTHER

Modified carbohydrate

Standard of Care

As determined by the study site

Group Type OTHER

Standard of Care

Intervention Type OTHER

As determined by the study site

Interventions

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Nutritional Supplement

Modified carbohydrate

Intervention Type OTHER

Standard of Care

As determined by the study site

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy authorization prior to any participation in the study.
* Obese (BMI ≥ 30) as determined by pre-pregnancy BMI.
* ≥18 years of age.
* ≥15+0 but ≤16+6 weeks gestation with a singleton pregnancy.
* Willing to follow supplementation protocol and follow appropriate nutritional guidance and refrain from consuming other caloric nutritional supplements that are not approved by the study staff, if applicable.
* Willing to provide body composition measures on infant at birth.
* Willing to consider additional measures if follow-up studies are conducted.

Exclusion Criteria

* Adverse maternal and/or fetal medical history which is expected to alter blood glucose regulations.
* Previously diagnosed diabetes, previous gestational diabetes, systemic lupus erythematodes, anti-phospholipid syndrome, known renal disease, treated hypertension, uncontrolled hypothyroidism and/or cancer.
* Taking medications that can impact blood glucose.
* Previous bariatric surgery.
* Lactose intolerant and/or has milk protein allergy or requires a special diet regime.
* Participating in another clinical trial that would impact participation in this study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes