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Effect of Polydextrose consumption on the composition of intestinal bacteria and blood sugar control in patients with Gestational Diabetes Mellitus

Effect of Polydextrose consumption of the intestinal microbiota, inflammatory and oxidative stress markers, immune profile, and glycemic control of patients with Gestational Diabetes Mellitus: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10dnk8pg
Enrollment
68
Registered
2025-04-29
Start date
2025-01-20
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Fiber. Gestational Diabetes

Interventions

A randomized clinical trial will be carried out with patients with GDM treated at the High-Risk Pregnancy Outpatient Clinic of the University Hospital HU/UFSC/EBSERH. Inclusion Criteria: Adult patient
Control Group - CG). GPDX patients will receive sachets containing 10g of polydextrose for 8 weeks. For both groups, food consumption, anthropometric measurements, composition of the intestinal microb

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Hospital Universitário Polydoro Ernani de São Thiago - HU/UFSC/EBSERH
Collaborator

Eligibility

Sex/Gender
Female
Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients over 19 years of age, with GDM diagnosed between 24 and 28 weeks of gestation by OGTT, who have a eutopic pregnancy, with only one embryo and who accept and sign the Informed Consent Form (TCLE).

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Alcoholism, alcoholism, drug use, presence of fetal malformations, psychiatric, neurological, autoimmune, renal, hepatic diseases, inflammatory bowel diseases, previous type 1 or 2 Diabetes Mellitus, immunodeficiencies, allergies or food intolerances, hyperemesis gravidarum, use of anti-inflammatory drugs in the last 30 days and use of antibiotics and supplements or complements containing pre, pro or synbiotics in the last 90 days.

Design outcomes

Primary

MeasureTime frame
It is expected that the consumption of polydextrose can help with glycemic homeostasis in patients with Gestational Diabetes Mellitus

Secondary

MeasureTime frame
It is expected that the consumption of polydextrose can bring positive effects on the intestinal microbiota of patients with GDM, modifying its composition based on genera and/or species of bacteria capable of helping to regulate energy metabolism, thus contributing to the reduction of the inflammatory process. subclinical and oxidative stress observed in this population.

Countries

BR

Contacts

Public ContactLaboratório HU/UFSC/EBSERH

Hospital Universitário Polydoro Ernani de São Thiago - HU/UFSC/EBSERH

viviane.rgs@ufsc.br+55(48)3721-8014

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 29, 2026