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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? (DiFiGDM)

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Supplementation with soluble fibre from guar (Optifibre©)
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, soluble fibre, dietary fibre, guar

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women diagnosed with GDM by a pathological OGTT. Second (13th to 28th week of pregnancy) and/or third trimester (29th to 40th week of pregnancy). Sufficient knowledge of German to perform self-monitoring correctly No intolerance to standardised meals (cereal porridge) or BST supplements No concomitant disease requiring special dietary management Exclusion Criteria: Existing diabetes mellitus type 1 or type 2 in pregnancy First trimester of pregnancy Intolerance/contraindications to any of the ingredients of Resource cereal© or Optifibre©. Insufficient language skills to perform self-monitoring Insufficient language skills to adequately implement study procedure/intervention

Sites / Locations

  • Landesklinikum MödlingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supplementation with soluble fibre from guar

No supplementation with soluble fibre from guar

Arm Description

In the intervention group, the patients consume the standardized meal instead of breakfast and add 10 g of soluble fiber in the form of Optifibre (food for special medical purposes) to this cereal porridge.

In the control group, the patients eat the standardized meal without adding soluble fiber in the form of Optifibre.

Outcomes

Primary Outcome Measures

postprandial blood glucose
postprandial blood glucose value in mg/dl with and without intervention

Secondary Outcome Measures

difference between fasting blood glucose value and postprandial blood glucose value
difference between fasting blood glucose value and postprandial blood glucose value in mg/dl with and without intervention

Full Information

First Posted
June 21, 2023
Last Updated
June 21, 2023
Sponsor
Medical University of Graz
Collaborators
Mödling Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05925010
Brief Title
Does Soluble Fiber Supplementation Result in Lower Postprandial Blood Glucose in Women With Gestational Diabetes Compared With no Supplementation After a Standardized Breakfast?
Acronym
DiFiGDM
Official Title
Does Soluble Fiber Supplementation Result in Lower Postprandial Blood Glucose in Women With Gestational Diabetes Compared With no Supplementation After a Standardized Breakfast? A Randomized, Controlled, Open-label, Prospective, Monocentric Clinical Cross-over Pilot Study at the Landesklinikum Mödling.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Mödling Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Background and study aims: The effect of supplementation of soluble dietary fiber from guar in the form of a dietary food for special medical purposes (Optifibre©) on postprandial glucose levels in women with gestational diabetes after a standardized test meal (Resource cereal porridge©) was consumed with or without supplementation is being investigated. The aim of this study is to verify whether the use of easily tolerated soluble dietary fiber in addition to nutritional therapy for gestational diabetes can lead to an improvement in glycemic control and thus represent a therapeutic option for diabetic diseases in the future. Participants: Women with gestational diabetes meeting the inclusion criteria. Study drain: Study participants are recruited via the appointment at the metabolic outpatient clinic of the Mödling district, where diabetes and nutrition training including training on the Contour Next One© blood glucose meter takes place as standard. If patients meet the inclusion criteria for participation in the study, the nutritional training is followed by an educational interview including signing of the consent form if the patient wishes to participate. After a one-week run-in phase, the participating patients are assigned to the intervention or control group by means of a randomizer. 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. The procedure is as follows: at the initial appointment in the metabolic outpatient clinic, the participant receives 2 sachets of a standardized cereal porridge, which represents the standardized breakfast, and 1 can of Optifibre©. In the control phase, the participant consumes the cereal porridge with 200ml of milk after fasting blood glucose is measured. 1 hour after consumption, the postprandial blood glucose value is measured and documented in self-monitoring. In the intervention phase, participants also replace breakfast with the same porridge, but consume an additional 10g of Optifibre© mixed into the porridge. As in the control phase, fasting blood glucose is measured beforehand and postprandial blood glucose is measured 1 hour after consumption, including documentation. Intervention and control phase take place consecutively after a wash-out phase of 2 days. During the wash-out phase, the general guidelines for nutrition in gestational diabetes will be followed, no supplementation with Optifibre© will be given. Participants send the records to difi.gdm@moedling.lknoe.at , the data are then pseudonymized and further processed with the appropriate verification code. The intervention itself lasts approximately 2 weeks per participant starting with initial training and ending with the transmission of the data. The total duration of the study is significantly longer, as recruitment is an ongoing process. It is assumed that the total duration of data collection will be at least 6 months, based on the estimate that 3 to 4 patients/week can be included and recruited for the study. Benefits and risks: If supplementation of the soluble fiber Guar shows a positive effect on glycemic control of a GDM, consumption of supplements such as Optifibre© represents another option for additional fiber intake and another therapeutic option for diabetic diseases in the future. There is no disadvantage for the participants in this study. All study participants receive the same nutritional medical training that is also given to non-study participants, and there is no different treatment of the subjects during the course of the study, since each subject undergoes both the intervention and control phases. Place where the study will be conducted: This study is conducted by the Landesklinikum Mödling in cooperation with the Medical University of Graz. Duration and schedule: The concept submission took place in May 2022 and the study will be completed in July 2023. Funding of the study: As this is a final thesis of the university course "Applied Nutritional Medicine" at the Medical University of Graz to obtain the Master of Science of applied nutritional medicine, there is no funding involved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, soluble fibre, dietary fibre, guar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplementation with soluble fibre from guar
Arm Type
Experimental
Arm Description
In the intervention group, the patients consume the standardized meal instead of breakfast and add 10 g of soluble fiber in the form of Optifibre (food for special medical purposes) to this cereal porridge.
Arm Title
No supplementation with soluble fibre from guar
Arm Type
No Intervention
Arm Description
In the control group, the patients eat the standardized meal without adding soluble fiber in the form of Optifibre.
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplementation with soluble fibre from guar (Optifibre©)
Intervention Description
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©).
Primary Outcome Measure Information:
Title
postprandial blood glucose
Description
postprandial blood glucose value in mg/dl with and without intervention
Time Frame
4 days
Secondary Outcome Measure Information:
Title
difference between fasting blood glucose value and postprandial blood glucose value
Description
difference between fasting blood glucose value and postprandial blood glucose value in mg/dl with and without intervention
Time Frame
4 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The subject of the study is gestational diabetes, which is why only women are included in the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women diagnosed with GDM by a pathological OGTT. Second (13th to 28th week of pregnancy) and/or third trimester (29th to 40th week of pregnancy). Sufficient knowledge of German to perform self-monitoring correctly No intolerance to standardised meals (cereal porridge) or BST supplements No concomitant disease requiring special dietary management Exclusion Criteria: Existing diabetes mellitus type 1 or type 2 in pregnancy First trimester of pregnancy Intolerance/contraindications to any of the ingredients of Resource cereal© or Optifibre©. Insufficient language skills to perform self-monitoring Insufficient language skills to adequately implement study procedure/intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva-Maria Marchard, BSc
Phone
00436765301973
Email
eva-maria.marchard@gmx.at
Facility Information:
Facility Name
Landesklinikum Mödling
City
Mödling
State/Province
Lower Austria
ZIP/Postal Code
2340
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nawras Al-Taie, Dr.
Email
nawras.altaie@reflex.at

12. IPD Sharing Statement

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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?

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