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

NCT05925010 | Unknown

• 1 other identifier: GS1-EK-4/809-2022
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; soluble fibre; dietary fibre; guar

Outcome Measures

Primary Outcomes (1)

• postprandial blood glucose

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

  4 days

Secondary Outcomes (1)

• difference between fasting blood glucose value and postprandial blood glucose value

  4 days

Study Arms (2)

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.

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.

Interventions

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©).

Supplementation with soluble fibre from guar

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: The subject of the study is gestational diabetes, which is why only women are included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Mödling Hospital: collaborator

Study Sites (1)

Landesklinikum Mödling

Mödling, Lower Austria, 2340, Austria

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Eva-Maria Marchard, BSc

CONTACT

00436765301973; eva-maria.marchard@gmx.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: January 2, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-02

Locations

AU (1)