Gestational DiabetesDiFiGDMNCT05925010
Does Soluble Fiber Supplementation Result in Lower Postprandial Blood Glucose in Women With Gestational Diabetes Compared With no Supplementation After a Standardized Breakfast?
A study testing Supplementation with soluble fibre from guar (Optifibre©) in people with Gestational Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Supplementation with soluble fibre from guar (Optifibre©)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jan 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Landesklinikum Mödling
Mödling, Lower Austria, 2340
Nawras Al-Taie, Dr., nawras.altaie@reflex.at
About this study
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.
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:
Read more
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Supplementation with soluble fibre from guar (Optifibre©)
- Keywords
- gestational diabetes, soluble fibre, dietary fibre, guar
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with soluble fibre from guar (Optifibre©)Dietary supplement
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©).
| Study group | Role | What they receive |
|---|---|---|
| Supplementation with soluble fibre from guar | Experimental | 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. Receives: Dietary Supplement: Supplementation with soluble fibre from guar (Optifibre©) |
| No supplementation with soluble fibre from guar | No intervention | In the control group, the patients eat the standardized meal without adding soluble fiber in the form of Optifibre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial blood glucose
postprandial blood glucose value in mg/dl with and without intervention
Measured: 4 days
Secondary outcomes (1)
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
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start2 Jan 2023
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Mödling Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925010
- Sponsor's protocol ID
- GS1-EK-4/809-2022
- Acronym
- DiFiGDM
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05925010
- Acronym / sponsor ID
- DiFiGDM / GS1-EK-4/809-2022
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, soluble fibre, dietary fibre, guar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Mödling Hospital
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation with soluble fibre from guar | Experimental | Dietary Supplement: Supplementation with soluble fibre from guar (Optifibre©)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. |
| No supplementation with soluble fibre from guar | No intervention | –In the control group, the patients eat the standardized meal without adding soluble fiber in the form of Optifibre. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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©). | Dietary supplement | Supplementation with soluble fibre from guar |
Primary outcome
postprandial blood glucose
Time frame: 4 days
postprandial blood glucose value in mg/dl with and without intervention
1 secondary outcome
difference between fasting blood glucose value and postprandial blood glucose value
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation with soluble fibre from guar (Optifibre©) in people with Gestational Diabetes, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva-Maria Marchard, BSc (00436765301973, eva-maria.marchard@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial blood glucose (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.