Nutritional Intervention During Gestation and Offspring Health

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: Maternal Glycemia
• Intervention / Treatment: Other: Nutritional Supplement; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	2 hour OGTT	27-28 weeks gestation

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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