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Behavioral Intervention
Reducing Artificial Sweeteners for Diabetes in Pregnancy
N/A
Recruiting
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-45 years of age
Be between 18 and 65 years old
Must not have
Physician diagnosis of a major medical illness (e.g. cancer, cardiovascular disease, chronic hypertension)
Physical or mental concerns preventing study participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month of age
Awards & highlights
Summary
This trial aims to understand how consuming non-nutritive sweeteners during pregnancy and breastfeeding affects infant obesity and health risks. Pregnant women who often consume these sweeteners will be divided into two groups
Who is the study for?
This trial is for pregnant women who often use non-nutritive sweeteners (NNS). They will be studied to see if avoiding NNS during pregnancy and breastfeeding affects their baby's risk of obesity and other health issues, as well as the mother's blood sugar levels.
What is being tested?
The study compares two groups: one that restricts NNS intake during pregnancy and lactation, and a control group with no restrictions. The impact on infant body composition, maternal glucose levels, and both the mother's and infant’s gut health are being observed.
What are the potential side effects?
Since this trial involves dietary changes rather than medication or medical procedures, side effects may include changes in maternal weight gain or cravings. Infants' reactions can't be predicted but will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a major illness like cancer or heart disease.
Select...
I do not have any physical or mental issues preventing me from joining the study.
Select...
My unborn baby has a confirmed or suspected genetic abnormality.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mothers' incremental area under glucose response curves
Secondary study objectives
Infants' adiposity
Infants' age-sex specific percentile
Infants' birthweight
+8 moreOther study objectives
Infants' gut microbiome composition
Mothers' C-reactive protein (CRP) concentration
Mothers' body composition during pregnancy
+2 moreTrial Design
3Treatment groups
Active Control
Group I: Control (Group 1)Active Control1 Intervention
Participants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention.
Group II: NNS Restriction in Lactation (Group 2)Active Control2 Interventions
Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
Group III: NNS Restriction in Pregnancy and Lactation (Group 3)Active Control1 Intervention
Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.
Find a Location
Who is running the clinical trial?
George Washington UniversityLead Sponsor
250 Previous Clinical Trials
458,486 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
244 Previous Clinical Trials
5,072,742 Total Patients Enrolled
Children's National Research InstituteOTHER
218 Previous Clinical Trials
257,586 Total Patients Enrolled
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