Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Materna… (NCT06548828) | Clinical Trial Compass
RecruitingNot Applicable
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
United States324 participantsStarted 2024-08-19
Plain-language summary
The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant
* ≤ 16 weeks gestation
* Singleton pregnancy
* Report frequent NNS beverage consumption (≥ 7 servings/week)
* 18-45 years of age
* Able to read English at a 5th grade level; and
* Intend to breastfeed for at least the first 6 months of life.
* For infants: The mother must be enrolled and provide assent for the infant to participate.
Exclusion Criteria:
* Physical or mental concerns preventing study participation;
* Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;
* Tobacco or drug use during pregnancy;
* Alcohol consumption (\>1 drink per week) during pregnancy;
* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;
* Known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.
* History of prior gastric bypass surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infants' adiposity
Timeframe: At 6 months of age
2
Mothers' incremental area under glucose response curves