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OpenTrials
Completed

NCT Number: NCT02285764

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital, München, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Nutritional Supplement

Other

Modified carbohydrate

Standard of care

Other

As determined by the study site

Primary outcomes

  1. Maternal Oral Glucose Tolerance Test (OGTT)

    Time frame: 27-28 weeks gestation

    2 hour OGTT

Secondary outcomes

  1. Neonatal Body Composition

    Time frame: Birth - 72 hours

  2. Maternal Fasting Blood Glucose

    Time frame: 34-36 weeks gestation

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • European Union

Registry information

Official study title

NIGO Health- Nutritional Intervention During Gestation and Offspring Health

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2014
Registry last updated
Jul 2, 2018

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.