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CompletedNCT02285764Updated Jul 2, 2018

Nutritional Intervention During Gestation and Offspring Health

An interventional study of Nutritional Supplement and Standard of Care in Maternal Glycemia, sponsored by Abbott Nutrition. Completed at 3 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
331
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Maternal Glycemia
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
331 participants (actual)

Study arms

  • Experimental
    Nutritional Supplement

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

    Other: Nutritional Supplement

  • Other
    Standard of Care

    As determined by the study site

    Other: Standard of Care

Interventions

  • OtherNutritional Supplement

    Modified carbohydrate

  • OtherStandard of Care

    As determined by the study site

06

What researchers measure

Primary outcomes

  1. Maternal Oral Glucose Tolerance Test (OGTT)

    2 hour OGTT

    Time frame: 27-28 weeks gestation

Secondary outcomes

  1. Neonatal Body Composition

    Time frame: Birth - 72 hours

  2. Maternal Fasting Blood Glucose

    Time frame: 34-36 weeks gestation

07

Study locations

3 sites
  • Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital
    München, 80337, Germany
  • University of Granda
    Granada, 11 18071, Spain
  • University Clinical Hospital San Cecilio
    Granada, 16 18012, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02285764
Lead sponsor
Abbott Nutrition
Collaborators
European Union
Responsible party
Sponsor
First posted
Nov 7, 2014
Start date
Dec 2014
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Jul 2, 2018

Study contacts

Elena Oliveros Delgado, BSc, MSc
study chair · Abbott Nutrition
Ricardo Rueda, MD, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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