AzTrials
AzTrials

Diabetes Mellitus, Type 2NCT03805802

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

A study testing active product and reference product in people with Diabetes Mellitus, Type 2 and Obesity, run by Stoffwechselzentrum Rhein - Pfalz at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2, Obesity, Overweight
What is being tested?
active product and reference product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteGermany
Study dates
4 Feb 2019to 1 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • insulin treatment
  • Psychiatric Disease
  • Acute Infections
  • Alcohol or drug abuse
  • Acute diverticulitis
  • Malignant tumors or hematologic disorders
Show all 11Show fewer
  • Heart failure NYHA III-IV
  • Acute coronary syndrome
  • Chronic kidney disease > Stage 3 (KDOQI)
  • Pregnancy or Lactation
  • Previous bariatric interventions

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Stoffwechselzentrum Rhein-Pfalz

    Mannheim, Baden-Wurttemberg, 68163

Other trials in Germany

About this study

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.

Read the 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.

Being tested
active product, reference product
Keywords
fiber, type 2 diabetes, dietary intervention, weight loss, glucose control, obesity, overweight, metabolic syndrome, oats
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight, Metabolic Syndrome, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active productOther

    Also called LOB, Liquid Oat Bran, High fiber product

    Once daily consumption over the period of the study

  • reference productOther

    Also called placebo food product

    Once daily consumption over the period of the study

Study groups in NCT03805802
Study groupRoleWhat they receive
active productExperimentalOnce 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).
Receives: Other: active product
reference productPlacebo comparatorOnce 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).
Receives: Other: active product; Other: reference product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

Secondary outcomes (27)

  1. 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.

    Measured: 12 weeks

  2. HBA1c

    long-term glucose control as measured by the concentratino of HbA1c concentration in %

    Measured: 6 weeks

  3. HBA1c

    long-term glucose control as measured by the concentratino of HbA1c concentration in %

    Measured: 12 weeks

  4. Self-documented glucose

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

    Measured: 6 weeks

  5. Self-documented glucose

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

    Measured: 12 weeks

  6. Weight

    Chenge in body Weight in kg

    Measured: 6 weeks

  7. Weight

    Chenge in body Weight in kg

    Measured: 12 weeks

  8. BMI

    Body Mass Index

    Measured: 6 weeks

  9. BMI

    Body Mass Index

    Measured: 12 weeks

  10. Lipid metabolism: Serum triglycerides

    Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)

    Measured: 6 weeks

  11. Lipid metabolism: Serum triglycerides

    Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)

    Measured: 12 weeks

  12. Lipid metabolism: apolipoprotein A (mg/dl)

    Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)

    Measured: 6 weeks

  13. Lipid metabolism: apolipoprotein A (mg/dl)

    Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)

    Measured: 12 weeks

  14. Lipid metabolism: Apolipoprotein B mg/dl

    Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl

    Measured: 6 weeks

  15. Lipid metabolism: Apolipoprotein B mg/dl

    Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl

    Measured: 12 weeks

  16. Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio

    Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio

    Measured: 6 weeks

  17. Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio

    Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio

    Measured: 12 weeks

  18. Lipid metabolism: HDL-cholesterol

    Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl

    Measured: 6 weeks

  19. Lipid metabolism: HDL-cholesterol

    Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl

    Measured: 12 weeks

  20. Lipid metabolism: LDL- cholesterol mg/dl

    Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl

    Measured: 6 weeks

  21. Lipid metabolism: LDL- cholesterol mg/dl

    Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl

    Measured: 12 weeks

  22. Microbiome

    Microbiome in faeces samples at 6 weeks

    Measured: 6 weeks

  23. Microbiome

    Microbiome in faeces samples at 12 weeks

    Measured: 12 weeks

  24. Inflammation: Il-6

    Markers of inflammation at 6 weeks IL-6 in ng/ml

    Measured: 6 weeks

  25. Inflammation: hsCRP

    Markers of inflammation at 6 weeks hsCRP mg/l

    Measured: 6 weeks

  26. Inflammation: Il-6

    Markers of inflammation at 12 weeks IL-6 in ng/ml

    Measured: 12 weeks

  27. Inflammation: hsCRP

    Markers of inflammation at 12 weeks hsCRP mg/l

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start4 Feb 2019
  3. Primary completion1 Apr 2020
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805802
Sponsor's protocol ID
012019
Status last verified
Oct 2020
First submitted
13 Jan 2019
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing active product and reference product in people with Diabetes Mellitus, Type 2 and Obesity, run by Stoffwechselzentrum Rhein - Pfalz at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting glucose (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in