Nutritional Intervention During Gestation and Offspring Health

June 29, 2018 updated by: Abbott Nutrition

NIGO Health- Nutritional Intervention During Gestation and Offspring Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

331

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional Supplement
One 237 ml oral supplement consumed two times a day; Not commercially available.
Other: Nutritional Supplement
Modified carbohydrate
Other: Standard of Care
As determined by the study site
Other: Standard of Care
As determined by the study site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Oral Glucose Tolerance Test (OGTT)
Time Frame: 27-28 weeks gestation
2 hour OGTT
27-28 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Neonatal Body Composition
Time Frame: Birth - 72 hours
Birth - 72 hours
Maternal Fasting Blood Glucose
Time Frame: 34-36 weeks gestation
34-36 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Collaborators

European Union

Investigators

  • Study Chair: Elena Oliveros Delgado, BSc, MSc, Abbott Nutrition
  • Study Chair: Ricardo Rueda, MD, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • AL10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe