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

October 20, 2020 updated by: Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks
HBA1c
Time Frame: 6 weeks
long-term glucose control as measured by the concentratino of HbA1c concentration in %
6 weeks
HBA1c
Time Frame: 12 weeks
long-term glucose control as measured by the concentratino of HbA1c concentration in %
12 weeks
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
6 weeks
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
12 weeks
Weight
Time Frame: 6 weeks
Chenge in body Weight in kg
6 weeks
Weight
Time Frame: 12 weeks
Chenge in body Weight in kg
12 weeks
BMI
Time Frame: 6 weeks
Body Mass Index
6 weeks
BMI
Time Frame: 12 weeks
Body Mass Index
12 weeks
Lipid metabolism: Serum triglycerides
Time Frame: 6 weeks
Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)
6 weeks
Lipid metabolism: Serum triglycerides
Time Frame: 12 weeks
Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)
12 weeks
Lipid metabolism: apolipoprotein A (mg/dl)
Time Frame: 6 weeks
Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)
6 weeks
Lipid metabolism: apolipoprotein A (mg/dl)
Time Frame: 12 weeks
Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)
12 weeks
Lipid metabolism: Apolipoprotein B mg/dl
Time Frame: 6 weeks
Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl
6 weeks
Lipid metabolism: Apolipoprotein B mg/dl
Time Frame: 12 weeks
Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl
12 weeks
Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
Time Frame: 6 weeks
Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
6 weeks
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
12 weeks
Lipid metabolism: HDL-cholesterol
Time Frame: 6 weeks
Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl
6 weeks
Lipid metabolism: HDL-cholesterol
Time Frame: 12 weeks
Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl
12 weeks
Lipid metabolism: LDL- cholesterol mg/dl
Time Frame: 6 weeks
Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl
6 weeks
Lipid metabolism: LDL- cholesterol mg/dl
Time Frame: 12 weeks
Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl
12 weeks
Microbiome
Time Frame: 6 weeks
Microbiome in faeces samples at 6 weeks
6 weeks
Microbiome
Time Frame: 12 weeks
Microbiome in faeces samples at 12 weeks
12 weeks
Inflammation: Il-6
Time Frame: 6 weeks
Markers of inflammation at 6 weeks IL-6 in ng/ml
6 weeks
Inflammation: hsCRP
Time Frame: 6 weeks
Markers of inflammation at 6 weeks hsCRP mg/l
6 weeks
Inflammation: Il-6
Time Frame: 12 weeks
Markers of inflammation at 12 weeks IL-6 in ng/ml
12 weeks
Inflammation: hsCRP
Time Frame: 12 weeks
Markers of inflammation at 12 weeks hsCRP mg/l
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic lood pressure
Time Frame: 6 weeks
Systolic blood pressure left arm 6 weeks in mm/Hg
6 weeks
Diastolic blood pressure
Time Frame: 6 weeks
Diastolic blood pressure left arm 6 weeks in mm/Hg
6 weeks
Systolic blood pressure
Time Frame: 12 weeks
Systolic blood pressure left arm 12 weeks in mm/Hg
12 weeks
Diastolic blood pressure
Time Frame: 12 weeks
Diastolic blood pressure left arm 12 weeks in mm/Hg
12 weeks
Waist circumference
Time Frame: 6 weeks
Waist circumference at 6 weeks in cm
6 weeks
Waist circumference
Time Frame: 12 weeks
Waist circumference at 12 weeks in cm
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stoffwechselzentrum Rhein - Pfalz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Glucanova AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Per M Humpert, M. D., Director of Stoffwechselzentrum Rhein-Pfalz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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