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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; Overweight; Metabolic Syndrome
• Intervention / Treatment: Other: active product; Other: reference product

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68163
      • Stoffwechselzentrum Rhein-Pfalz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active product; 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).	Other: active product; Once daily consumption over the period of the study; Other Names: LOB; Liquid Oat Bran; High fiber product
Placebo Comparator: reference product; 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).	Other: active product; Once daily consumption over the period of the study; Other Names: LOB; Liquid Oat Bran; High fiber product; Other: reference product; Once daily consumption over the period of the study; Other Names: placebo food product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	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.	12 weeks
HBA1c	long-term glucose control as measured by the concentratino of HbA1c concentration in %	6 weeks
HBA1c	long-term glucose control as measured by the concentratino of HbA1c concentration in %	12 weeks
Self-documented glucose	Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl	6 weeks
Self-documented glucose	Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl	12 weeks
Weight	Chenge in body Weight in kg	6 weeks
Weight	Chenge in body Weight in kg	12 weeks
BMI	Body Mass Index	6 weeks
BMI	Body Mass Index	12 weeks
Lipid metabolism: Serum triglycerides	Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)	6 weeks
Lipid metabolism: Serum triglycerides	Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)	12 weeks
Lipid metabolism: apolipoprotein A (mg/dl)	Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)	6 weeks
Lipid metabolism: apolipoprotein A (mg/dl)	Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)	12 weeks
Lipid metabolism: Apolipoprotein B mg/dl	Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl	6 weeks
Lipid metabolism: Apolipoprotein B mg/dl	Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl	12 weeks
Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio	Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio	6 weeks
Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio	Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio	12 weeks
Lipid metabolism: HDL-cholesterol	Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl	6 weeks
Lipid metabolism: HDL-cholesterol	Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl	12 weeks
Lipid metabolism: LDL- cholesterol mg/dl	Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl	6 weeks
Lipid metabolism: LDL- cholesterol mg/dl	Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl	12 weeks
Microbiome	Microbiome in faeces samples at 6 weeks	6 weeks
Microbiome	Microbiome in faeces samples at 12 weeks	12 weeks
Inflammation: Il-6	Markers of inflammation at 6 weeks IL-6 in ng/ml	6 weeks
Inflammation: hsCRP	Markers of inflammation at 6 weeks hsCRP mg/l	6 weeks
Inflammation: Il-6	Markers of inflammation at 12 weeks IL-6 in ng/ml	12 weeks
Inflammation: hsCRP	Markers of inflammation at 12 weeks hsCRP mg/l	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic lood pressure	Systolic blood pressure left arm 6 weeks in mm/Hg	6 weeks
Diastolic blood pressure	Diastolic blood pressure left arm 6 weeks in mm/Hg	6 weeks
Systolic blood pressure	Systolic blood pressure left arm 12 weeks in mm/Hg	12 weeks
Diastolic blood pressure	Diastolic blood pressure left arm 12 weeks in mm/Hg	12 weeks
Waist circumference	Waist circumference at 6 weeks in cm	6 weeks
Waist circumference	Waist circumference at 12 weeks in cm	12 weeks

Collaborators and Investigators

• Sponsor: Stoffwechselzentrum Rhein - Pfalz
• Collaborators: Glucanova AB
• Investigators: Principal Investigator: Per M Humpert, M. D., Director of Stoffwechselzentrum Rhein-Pfalz

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: obesity; overweight; type 2 diabetes; glucose control; weight loss; metabolic syndrome; dietary intervention; fiber; oats
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Overweight
• Other Study ID Numbers: 012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No