NCT06867861

Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes

Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.

Detailed description

The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fiber	Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-02-24
• Completion: 2026-08-26
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States