Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.

It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.

fiber, type 2 diabetes, dietary intervention, weight loss, glucose control, obesity, overweight, metabolic syndrome, oats

First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.

The investigator receives reference product and the test product in boxes labelled "stratus" "nimbus" and "cumulus". first 6 weeks participants are randomly assigned to "stratus" or "nimbus" and the second 6 weeks participants all receive "cumulus".

Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).

Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).

Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.

Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks.

Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl

Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl

Inclusion Criteria: Type 2 Diabetes with inadequate glucose control and a HbA1c >7,5 and < 9% Treatment with all oral antidiabetic medication or injectable GLP-1 analogues BMI 28,0-39,9 kg/m² Age 30-70 years Exclusion Criteria: insulin treatment Psychiatric Disease Acute Infections Alcohol or drug abuse Acute diverticulitis Malignant tumors or hematologic disorders Heart failure NYHA III-IV Acute coronary syndrome Chronic kidney disease > Stage 3 (KDOQI) Pregnancy or Lactation Previous bariatric interventions