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?

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.

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 fiber supplementation safe for pregnant women with gestational diabetes?

Fiber supplementation is generally considered safe for pregnant women, including those with gestational diabetes. Studies show that it can help manage blood sugar levels and improve pregnancy outcomes without significant safety concerns. ^{1 2 3 4 5}

How does fiber supplementation differ from other treatments for gestational diabetes?

Fiber supplementation for gestational diabetes is unique because it focuses on increasing dietary fiber intake, which can help control blood sugar levels and improve pregnancy outcomes. Unlike medications, fiber works by slowing down digestion and stabilizing blood sugar levels naturally, making it a non-pharmacological option for managing gestational diabetes. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Fiber for gestational diabetes?

Research shows that adding dietary fiber to the diet of pregnant women with gestational diabetes can significantly lower blood sugar levels and improve pregnancy outcomes, such as reducing the chances of preterm delivery and cesarean delivery. ^{1 4 5 7 8}

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

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. China 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. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Interventional effect of dietary fiber on blood glucose and pregnancy outcomes in patients with gestational diabetes mellitus. [2022]

3. Switzerland 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. [2023]

4. United States 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. [2022]

5. Germany 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[The metabolic impact of fiber in gestational diabetes]. [2022]

7. Switzerland 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Do fiber-enriched diabetic diets have glucose-lowering effects in pregnancy? [2017]