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Nutritional Intervention During Gestation and Offspring Health

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ClinicalTrials.gov Identifier: NCT02285764
Recruitment Status : Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Abbott Nutrition

Brief 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.

Condition or disease Intervention/treatment Phase
Maternal Glycemia Other: Nutritional Supplement Other: Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: NIGO Health- Nutritional Intervention During Gestation and Offspring Health
Actual Study Start Date : December 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Nutritional Supplement
One 237 ml oral supplement consumed two times a day; Not commercially available.
Other: Nutritional Supplement
Modified carbohydrate

Standard of Care
As determined by the study site
Other: Standard of Care
As determined by the study site




Primary Outcome Measures :
  1. Maternal Oral Glucose Tolerance Test (OGTT) [ Time Frame: 27-28 weeks gestation ]
    2 hour OGTT


Secondary Outcome Measures :
  1. Neonatal Body Composition [ Time Frame: Birth - 72 hours ]
  2. Maternal Fasting Blood Glucose [ Time Frame: 34-36 weeks gestation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285764


Locations
Germany
Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital
München, Germany, 80337
Spain
University of Granda
Granada, Spain, 11 18071
University Clinical Hospital San Cecilio
Granada, Spain, 16 18012
Sponsors and Collaborators
Abbott Nutrition
European Union
Investigators
Study Chair: Elena Oliveros Delgado, BSc, MSc Abbott Nutrition
Study Chair: Ricardo Rueda, MD, PhD Abbott Nutrition

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02285764     History of Changes
Other Study ID Numbers: AL10
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided