Fiber Supplementation for Gestational Diabetes

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Eastern Virginia Medical School

Disqualifiers: Non-English, Fetal anomaly, Bowel disorder, Phenylketonuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 7 months

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if fiber supplements can reduce medication needs and improve health outcomes for women with gestational diabetes and their babies. Participants will either take psyllium fiber capsules daily or no fiber to compare results. Pregnant women with one baby, diagnosed with gestational diabetes but not yet requiring medication, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of dietary changes on managing gestational diabetes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that fiber supplementation is safe for gestational diabetes patients?

Research has shown that fiber supplements are safe for pregnant women. One study found that regular fiber use during pregnancy is generally well-tolerated, with most experiencing no serious side effects. Another study found that adding fiber to the diet improved health in women with gestational diabetes by managing blood sugar levels and other pregnancy-related issues. Overall, existing research suggests that fiber supplements are safe and may offer health benefits for those with gestational diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for gestational diabetes, which often involve dietary changes, insulin, or medications like metformin, this experimental approach uses psyllium fiber supplements. Researchers are excited about this treatment because it leverages a natural ingredient, soluble fiber, which can help manage blood sugar levels in a simple, non-invasive way. By providing 16g of supplemental soluble fiber daily, the treatment aims to support glucose control without the potential side effects associated with medication. This could offer a safer, more accessible option for pregnant women managing gestational diabetes.

What evidence suggests that fiber supplementation might be an effective treatment for gestational diabetes?

Research has shown that fiber supplements can help with gestational diabetes. One study found that participants taking fiber supplements had a significantly lower rate of gestational diabetes—8.3% compared to 24.0% in those who did not take them. Other studies suggest that fiber supplements can improve the body's food processing and lead to better pregnancy outcomes. Additionally, insufficient fiber intake is strongly linked to a higher risk of developing gestational diabetes. In this trial, participants will receive either psyllium fiber supplement capsules or no fiber supplementation. Overall, these findings suggest that adding fiber to the diet could help manage gestational diabetes and reduce the need for medication. ^{1 2 3 5 6}

Who Is on the Research Team?

Jerri Waller, MD

Principal Investigator

Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals diagnosed with gestational diabetes. It's designed to see if adding fiber to their diet can reduce the need for medication and improve outcomes for both the mother and baby.

Inclusion Criteria

Singleton gestation

Known or new diagnosis of gestational diabetes without reason for medication

Exclusion Criteria

Prisoners

I have a diagnosed condition affecting my lower bowel.

Non-English as primary language

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fiber supplementation or no supplementation throughout pregnancy

Up to 7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fiber

Trial Overview The study is testing whether fiber supplements can help control blood sugar in patients with gestational diabetes, potentially reducing the need for other medications. Participants will be randomly assigned to receive either fiber supplements or no supplements.

How Is the Trial Designed?

Group I: Fiber Experimental Treatment 1 Intervention

Participants will 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.

Group II: No Fiber Active Control 1 Intervention

Participants will receive no fiber supplementation capsules.

Who Is Running the Clinical Trial?

Eastern Virginia Medical School

Lead Sponsor

Trials

77

Recruited

16,500+

Published Research Related to This Trial

Pregnant women, including those with gestational diabetes, are advised to increase their fiber intake to around 28g per day, similar to general population recommendations.

Viscous soluble fibers are particularly beneficial for improving glycemic control, suggesting that targeted fiber supplementation could enhance dietary management for gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The metabolic impact of fiber in gestational diabetes]. Schenk, S., Andrey, M., Vuignier, Y., et al.[2022]

Dietary fiber supplementation significantly improved blood glucose control in pregnant women with gestational diabetes, reducing fasting glucose, postprandial glucose, and glycated hemoglobin levels, based on a meta-analysis of 8 trials.

Insoluble dietary fiber was found to be more effective than soluble fiber in lowering fasting glucose levels, suggesting that higher doses (≥12 g/day) may be beneficial, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Additional Dietary Fiber Supplements on Pregnant Women with Gestational Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. Sun, J., Wang, J., Ma, W., et al.[2023]

A pilot study involving pregnant women with gestational diabetes tested a fiber-enriched diet, starting at 40 grams and increasing to a maximum of 80 grams of fiber per day, but found no significant reduction in blood glucose levels.

Despite good patient tolerance and compliance with the fiber-enriched diet, including a commercially available fiber supplement, the study concluded that increasing dietary fiber did not effectively lower blood glucose compared to a standard low-fiber diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do fiber-enriched diabetic diets have glucose-lowering effects in pregnancy? Reece, EA., Hagay, Z., Caseria, D., et al.[2017]

Dietary fiber supplementation in advanced maternal age Chinese women did not significantly reduce the incidence of gestational diabetes mellitus (GDM), with rates of 21.6% in the fiber group compared to 12.9% in the control group.

However, the fiber group showed improvements in glucose metabolism, reduced weight gain between 20 and 25 weeks, and lower rates of preterm birth, suggesting potential benefits beyond just GDM prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dietary Fiber on the Risk of Gestational Diabetes Mellitus in Advanced Maternal Age Women: Study Protocol for a Randomized Controlled Trial. Zhang, D., Sheng, J., Chen, L., et al.[2023]

A study involving 139 women at high risk for gestational diabetes mellitus (GDM) found that a low-glycemic index (LGI) diet resulted in a significantly lower glycemic index compared to a high-fiber (HF) diet, but both diets produced similar pregnancy outcomes.

There were no significant differences in key health metrics such as birth weight, maternal metabolic profiles, or the incidence of GDM between the LGI and HF diet groups, suggesting that both dietary approaches are effective for managing pregnancy in women at risk for GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Investigating the Effects of a Low-Glycemic Index Diet on Pregnancy Outcomes in Women at High Risk of Gestational Diabetes Mellitus: The GI Baby 3 Study. Markovic, TP., Muirhead, R., Overs, S., et al.[2022]

In a study of 98 overweight or obese pregnant women, those who took a dietary fiber supplement significantly reduced their risk of developing gestational diabetes mellitus (GDM) compared to those who received standard prenatal care (8.3% vs. 24.0%).

The fiber supplement group also experienced less excessive weight gain during pregnancy and had no cases of preterm birth, while the control group had a 12% preterm birth rate, indicating potential benefits of dietary fiber for both maternal and fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary fiber supplement on prevention of gestational diabetes mellitus in women with pre-pregnancy overweight/obesity: A randomized controlled trial. Zhang, DY., Cheng, DC., Cao, YN., et al.[2022]

In a study of 112 pregnant women with gestational diabetes, adding dietary fiber to their nutrition support significantly improved blood glucose levels, particularly post-meal glucose, over an 8-week period.

The dietary fiber group not only had better glucose control but also experienced fewer adverse perinatal outcomes, such as premature rupture of membranes and neonatal hyperbilirubinemia, compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventional effect of dietary fiber on blood glucose and pregnancy outcomes in patients with gestational diabetes mellitus. Zhang, Z., Li, J., Hu, T., et al.[2022]

In a study of 162 women with gestational diabetes mellitus (GDM) matched with 324 controls, higher intake of total fiber and fruit fiber during the second trimester was linked to a significantly reduced risk of GDM, with odds ratios indicating strong protective effects.

Conversely, higher consumption of cereal fiber and glycemic load during the same period was associated with an increased risk of GDM, suggesting that not all types of fiber have the same impact on gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber intake, dietary glycemic load, and the risk of gestational diabetes mellitus during the second trimester: A nested case-control study. Xu, Q., Tao, Y., Zhang, Y., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9465204/

The effect of dietary fiber supplement on prevention ... Results: The incidence of GDM was significantly reduced in the fiber supplement group compared with the control group: 8.3 vs. 24.0% (χ2 = 4.40, ...

2. pubs.rsc.org pubs.rsc.org/en/content/articlehtml/2024/fo/d3fo05120j

Effects of dietary fiber on maternal health in pregnant women ... Our findings revealed a significant correlation between insufficient dietary fiber intake and an increased risk of GDM.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9658588/

Effects of Additional Dietary Fiber Supplements on ... Our meta-analysis showed that dietary fiber supplementation significantly improved glycolipid metabolism and pregnancy outcomes in gestational diabetes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06867861

Effect of Fiber Supplementation on the Need for Medication ... The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09080-6

Effects of soluble dietary fiber on glycolipid metabolism in ... Accumulating evidence suggests that additional dietary fiber supplements may significantly improve glycolipid metabolism and pregnancy outcomes ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622001468

Dietary Blueberry and Soluble Fiber Supplementation ... Dietary Blueberry and Soluble Fiber Supplementation Reduces Risk of Gestational Diabetes in Women with Obesity in a Randomized Controlled Trial.