Food Product for Management of Gestational Diabetes

A Food Product for Glucose Management in Gestational Diabetes Mellitus - a Pilot Study

The goal of this pilot open pre-post clinical trial is to test effects of a wholegrain product in patients with newly diagnosed gestational diabetes. The main question it aims to answer is:

Does the wholegrain product improve glucose tolerance and insulin sensitivity during a 75 g oral glucose tolerance test (OGTT).

Participants will consume product on two consecutive evenings shortly after the first OGTT and will then perform a second OGTT. Researchers will compare the results of the first and second OGTT to see if glucose tolerance improved after consumption of the test product.

Inclusion Criteria:

1. Pathological fasting glucose or OGTT according to WHO-criteria for the diagnosis of gestational diabetes (see Table 1).
2. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
3. Willingness to complete questionnaires and follow instructions associated with the study and to perform another OGTT at the clinic in a second visit.
4. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

1. Type 2 diabetes prior to pregnancy
2. Psychiatric Disease
3. Acute Infections
4. Alcohol or drug abuse
5. Acute diverticulitis
6. Malignant tumors or hematologic disorders
7. Heart failure stages III-IV according to New York Heart Association (NYHA)
8. Acute coronary syndrome
9. Chronic kidney disease > Stage 3 (Kidney Disease Outcomes Quality Initiative - KDOQI)
10. Celiac disease
11. Diagnosed Inflammatory bowel diseases (mainly Crohn´s, Ulcerative colitis)
12. Allergy to ingredients included in the investigational product.
13. Use of antibiotics within 2 weeks of enrollment
14. Use of probiotics within 2 weeks of enrollment