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

• ClinicalTrials.gov Identifier: NCT03805802
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: October 22, 2020
• Sponsor: Stoffwechselzentrum Rhein - Pfalz
• Collaborator: Glucanova AB
• Information provided by (Responsible Party): Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Obesity; Overweight; Metabolic Syndrome	Other: active product; Other: reference product	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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".
• Primary Purpose: Treatment
• Official Title: Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
• Actual Study Start Date: February 4, 2019
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: April 1, 2020

Arms and Interventions

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 Name: placebo food product

Outcome Measures

Primary Outcome Measures :

1. Fasting glucose [ Time Frame: 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 6 weeks.

Secondary Outcome Measures :

1. Fasting glucose [ Time Frame: 12 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.
2. HBA1c [ Time Frame: 6 weeks ]
   long-term glucose control as measured by the concentratino of HbA1c concentration in %
3. HBA1c [ Time Frame: 12 weeks ]
   long-term glucose control as measured by the concentratino of HbA1c concentration in %
4. Self-documented glucose [ Time Frame: 6 weeks ]
   Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
5. Self-documented glucose [ Time Frame: 12 weeks ]
   Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
6. Weight [ Time Frame: 6 weeks ]
   Chenge in body Weight in kg
7. Weight [ Time Frame: 12 weeks ]
   Chenge in body Weight in kg
8. BMI [ Time Frame: 6 weeks ]
   Body Mass Index
9. BMI [ Time Frame: 12 weeks ]
   Body Mass Index
10. Lipid metabolism: Serum triglycerides [ Time Frame: 6 weeks ]
    Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)
11. Lipid metabolism: Serum triglycerides [ Time Frame: 12 weeks ]
    Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)
12. Lipid metabolism: apolipoprotein A (mg/dl) [ Time Frame: 6 weeks ]
    Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)
13. Lipid metabolism: apolipoprotein A (mg/dl) [ Time Frame: 12 weeks ]
    Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)
14. Lipid metabolism: Apolipoprotein B mg/dl [ Time Frame: 6 weeks ]
    Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl
15. Lipid metabolism: Apolipoprotein B mg/dl [ Time Frame: 12 weeks ]
    Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl
16. Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio [ Time Frame: 6 weeks ]
    Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
17. Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio [ Time Frame: 12 weeks ]
    Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
18. Lipid metabolism: HDL-cholesterol [ Time Frame: 6 weeks ]
    Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl
19. Lipid metabolism: HDL-cholesterol [ Time Frame: 12 weeks ]
    Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl
20. Lipid metabolism: LDL- cholesterol mg/dl [ Time Frame: 6 weeks ]
    Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl
21. Lipid metabolism: LDL- cholesterol mg/dl [ Time Frame: 12 weeks ]
    Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl
22. Microbiome [ Time Frame: 6 weeks ]
    Microbiome in faeces samples at 6 weeks
23. Microbiome [ Time Frame: 12 weeks ]
    Microbiome in faeces samples at 12 weeks
24. Inflammation: Il-6 [ Time Frame: 6 weeks ]
    Markers of inflammation at 6 weeks IL-6 in ng/ml
25. Inflammation: hsCRP [ Time Frame: 6 weeks ]
    Markers of inflammation at 6 weeks hsCRP mg/l
26. Inflammation: Il-6 [ Time Frame: 12 weeks ]
    Markers of inflammation at 12 weeks IL-6 in ng/ml
27. Inflammation: hsCRP [ Time Frame: 12 weeks ]
    Markers of inflammation at 12 weeks hsCRP mg/l

Other Outcome Measures:

1. Systolic lood pressure [ Time Frame: 6 weeks ]
   Systolic blood pressure left arm 6 weeks in mm/Hg
2. Diastolic blood pressure [ Time Frame: 6 weeks ]
   Diastolic blood pressure left arm 6 weeks in mm/Hg
3. Systolic blood pressure [ Time Frame: 12 weeks ]
   Systolic blood pressure left arm 12 weeks in mm/Hg
4. Diastolic blood pressure [ Time Frame: 12 weeks ]
   Diastolic blood pressure left arm 12 weeks in mm/Hg
5. Waist circumference [ Time Frame: 6 weeks ]
   Waist circumference at 6 weeks in cm
6. Waist circumference [ Time Frame: 12 weeks ]
   Waist circumference at 12 weeks in cm

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Germany

Stoffwechselzentrum Rhein-Pfalz

Mannheim, Baden-Württemberg, Germany, 68163

Sponsors and Collaborators

Stoffwechselzentrum Rhein - Pfalz

Glucanova AB

Investigators

• Principal Investigator: Per M Humpert, M. D.; Director of Stoffwechselzentrum Rhein-Pfalz

More Information

• Responsible Party: Dr. Per Humpert, Director of Stoffwechselzentrum Rhein - Pfalz, Stoffwechselzentrum Rhein - Pfalz
• ClinicalTrials.gov Identifier: NCT03805802
• Other Study ID Numbers: 012019
• First Posted: January 16, 2019
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz:

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

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Overweight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Insulin Resistance; Hyperinsulinism