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Does Soluble Fiber Supplementation Result in Lower Postprandial Blood Glucose in Women With Gestational Diabetes Compared With no Supplementation After a Standardized Breakfast?

NCT05925010 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-06-29

No results posted yet for this study

Summary

The objective of this study is to investigate the effect of supplementation of 10g soluble fiber from guar on postprandial blood glucose levels in women with gestational diabetes after consumption of a standardized meal compared with no supplementation.

Null Hypothesis H0:

Soluble fiber supplementation will not result in a lower postprandial blood glucose increase in women with gestational diabetes compared to no supplementation after consumption of a standardized meal.

Alternative hypothesis H1:

Soluble fiber supplementation will result in a lower postprandial blood glucose increase in women with gestational diabetes compared to no supplementation after consumption of a standardized meal.

Study participants are randomly assigned to the intervention (consumption of a standardized meal and 10g soluble fibre) or control group (consumption of a standardized meal without soluble fibre). After a 2-day wash-out phase, the two groups are switched (the intervention group becomes the control group and vice versa) with the same standardized procedure.

Conditions

  • Gestational Diabetes

Interventions

DIETARY_SUPPLEMENT

Supplementation with soluble fibre from guar (Optifibre©)

10g of soluble fibre from guar in the form of Optifibre© (dietary food for special medical purposes) is added to the standardized meal (Resource cereal porridge©).

Sponsors & Collaborators

  • Mödling Hospital

    collaborator OTHER

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05925010 on ClinicalTrials.gov