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

Stoffwechselzentrum Rhein - Pfalz

Status: Completed

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome

Treatments: Other: active product; Other: reference product

Study type: Interventional

Funder types: Other

Identifiers

NCT03805802

012019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

active product

Experimental group

Description:

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).

Treatment:

Other: active product

reference product

Placebo Comparator group

Description:

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).

Treatment:

Other: reference product

Other: active product