Maternal GlycemiaNCT02285764
Nutritional Intervention During Gestation and Offspring Health
A study testing Nutritional Supplement in people with Maternal Glycemia, run by Abbott Nutrition at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Glycemia
- What is being tested?
- Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
University of Granda
Granada, 11 18071
University Clinical Hospital San Cecilio
Granada, 16 18012
Germany1 site
Ludwig-Maximilians-University of Munich, Dr. von Hauner Children's Hospital
München, 80337
About this study
Official title: 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.
- Conditions
- Maternal Glycemia
- Being tested
- Nutritional Supplement, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementOther
Modified carbohydrate
Standard of CareOther
As determined by the study site
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement | Experimental | One 237 ml oral supplement consumed two times a day; Not commercially available. Receives: Other: Nutritional Supplement |
| Standard of Care | Other | As determined by the study site Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Oral Glucose Tolerance Test (OGTT)
2 hour OGTT
Measured: 27-28 weeks gestation
Secondary outcomes (2)
Neonatal Body Composition
Measured: Birth - 72 hours
Maternal Fasting Blood Glucose
Measured: 34-36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal GlycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Elena Oliveros Delgado, BSc, MSc, Study chair, Abbott NutritionRicardo Rueda, MD, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285764
- Sponsor's protocol ID
- AL10
- Status last verified
- Jun 2018
- First submitted
- 4 Nov 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
G Bermudez M, Garcia-Ricobaraza M, Garcia-Santos JA, Segura MT, Puertas-Prieto A, Gallo-Vallejo JL, Padilla-Vinuesa C, Koletzko B, Baggs GE, Oliveros E, Rueda R, Campoy C. Effect of a Low Glycemic Index/Slow Digesting (LGI/SD) Carbohydrate Product on Maternal Glycemia and Neonatal Body Composition in Obese Pregnant Women: The NIGOHealth Randomized Clinical Trial. Nutrients. 2025 Jun 5;17(11):1942. doi: 10.3390/nu17111942.
PubMed 40507210
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIGO Health- Nutritional Intervention During Gestation and Offspring Health
- ClinicalTrials.gov ID
- NCT02285764
- Acronym / sponsor ID
- AL10
- Conditions
- Maternal Glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- European Union
- Study start
- Dec 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Experimental | Other: Nutritional SupplementOne 237 ml oral supplement consumed two times a day; Not commercially available. |
| Standard of Care | Other | Other: Standard of CareAs determined by the study site |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional SupplementModified carbohydrate | Other | Nutritional Supplement |
| Standard of CareAs determined by the study site | Other | Standard of Care |
Primary outcome
Maternal Oral Glucose Tolerance Test (OGTT)
Time frame: 27-28 weeks gestation
2 hour OGTT
2 secondary outcomes
Neonatal Body Composition
Time frame: Birth - 72 hours
Maternal Fasting Blood Glucose
Time frame: 34-36 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Derived from this study: PubMed 40507210G Bermudez M, Garcia-Ricobaraza M, Garcia-Santos JA, Segura MT, Puertas-Prieto A, Gallo-Vallejo JL, Padilla-Vinuesa C, Koletzko B, Baggs GE, Oliveros E, Rueda R, Campoy C. Effect of a Low Glycemic Index/Slow Digesting (LGI/SD) Carbohydrate Product on Maternal Glycemia and Neonatal Body Composition in Obese Pregnant Women: The NIGOHealth Randomized Clinical Trial. Nutrients. 2025 Jun 5;17(11):1942. doi: 10.3390/nu17111942.
- Individual participant dataSharing planned: Undecided
Related trials for Maternal Glycemia
Not yet recruitingObservational study
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
Recruiting
Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY
Continuous Glucose Monitoring, Diabetes, Gestational
Active, not recruitingObservational study
Maternal Stress and Blood Sugar Metabolization
Pregnancy
Active, not recruitingObservational study
Gestational Diabetes Monitoring and Management
Gestational Diabetes, Pregnancy Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Oliveros Delgado, BSc, MSc study chair
Abbott Nutrition
Ricardo Rueda, MD, PhD study chair
Abbott Nutrition
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement in people with Maternal Glycemia, run by Abbott Nutrition at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Oral Glucose Tolerance Test (OGTT) (time frame: 27-28 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.