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Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients (NIMROD)

Primary Purpose

Type 2 Diabetes, NAFLD

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Drinking powder supplement
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring insoluble cereal fiber, insulin resistance, glucose tolerance, inflammation, incretins

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: type 2 diabetes mellitus HOMA-IR > 2.5 NAFLD (MR-S > 5,56 %) Exclusion Criteria: insulin treatment diabetes type 1, 3 or 4 severe cardiopulmonary, renal, inflammatory, gastrointestinal, psychiatric or endocrine disorder alcohol abuse or excess alcohol intake recent CVD event (< 3months) relevant liver disease other than NAFLD current cancer diagnosis or treatment allergy or incompatibility to the supplement

Sites / Locations

  • Charite University Hospital BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Supplementation with insoluble cereal fiber

Supplementation with placebo

Arm Description

Drinking powder supplement providing 7,5 grams of insoluble fiber per sachet, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity

Drinking powder supplement providing no insoluble fiber, but maltodextrin, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity

Outcomes

Primary Outcome Measures

change in liver fat content (MRS)
change in liver fat content (MRS)
change in glucose tolerance (mixed-meal test)
change in glucose tolerance (mixed-meal test)
change in insulin resistance (Matsuda)
change in insulin resistance (Matsuda)

Secondary Outcome Measures

change in fasting glucose
change in fasting glucose
change in HbA1c
change in HbA1c
change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22
change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22
change in incretins (GLP-1, GIP, PYY)
change in incretins (GLP-1, GIP, PYY)
change in FGF21
change in FGF21
change in IGF-1 and its binding proteins
change in IGF-1 and its binding proteins

Full Information

First Posted
December 8, 2022
Last Updated
September 20, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Wilhelm-Doerenkamp-Foundation (Funding)
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1. Study Identification

Unique Protocol Identification Number
NCT05654805
Brief Title
Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
Acronym
NIMROD
Official Title
Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Wilhelm-Doerenkamp-Foundation (Funding)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cohort studies show an association between increased intake of insoluble (cereal) fiber and decreased risk for cardiovascular disease, type 2 diabetes (T2DM), non-alcoholic fatty liver disease (NAFLD), cancer, infectious and inflammatory disorders. Intervention studies, specifically addressing non-fermentable carbohydrates instead of their food sources (whole grain, pulses, legumes) are still sparse. Whole grain trials reported beneficial effects, but cannot pinpoint these benefits on fiber, as minerals, vitamins, grain protein and food matrix contribute to the metabolic results. The antidiabetic effectiveness of cereal fiber might be explained by a) an increased secretion of incretins and other glucose-induced gastrointestinal hormones, b) an alteration of the gut microbiome, or c) a fermentation to short-chain fatty acids. Fermentable fibers (most of which are soluble) show these mechanisms, but lack strong diabetes-protective associations in cohort studies. In recent supplementation trials, insoluble, mostly non-fermentable fibers improved insulin resistance, glycemia and inflammation in patients with metabolic syndrome or prediabetes. Between 2022-2024, we want to assess the effectiveness of insoluble, poorly fermentable cereal fiber in a shorter Intervention period in patients with high responsiveness (insulin-naïve overt type 2 diabetes mellitus with insulin resistance and NAFLD), using a fiber drinking supplement. Our triple-blinded RCT compares the metabolic effects and mechanistic outcomes of isocaloric treatments with 15 grams of oat-fiber supplement per day (vs. placebo) in 92 patients, covering an intervention period of 12 weeks.
Detailed Description
Cohort studies show an association between increased intake of insoluble (cereal) fiber and decreased risk for cardiovascular disease, type 2 diabetes (T2DM), non-alcoholic fatty liver disease (NAFLD), cancer, infectious and inflammatory disorders. Intervention studies, specifically addressing non-fermentable carbohydrates instead of their food sources (whole grain, pulses, legumes) are still sparse. Whole grain trials reported beneficial effects, but cannot pinpoint these benefits on fiber, as minerals, vitamins, grain protein and food matrix contribute to the metabolic results. The antidiabetic effectiveness of cereal fiber might be explained by a) an increased secretion of incretins and other glucose-induced gastrointestinal hormones, b) an alteration of the gut microbiome, or c) a fermentation to short-chain fatty acids. Fermentable fibers (most of which are soluble) show these mechanisms, but lack strong diabetes-protective associations in cohort studies. In recent supplementation trials, insoluble, mostly non-fermentable fibers improved insulin resistance, glycemia and inflammation in patients with metabolic syndrome or prediabetes. Between 2022-2024, we want to assess the effectiveness of insoluble, poorly fermentable cereal fiber in a shorter Intervention period in patients with high responsiveness (insulin-naïve overt type 2 diabetes mellitus with insulin resistance and NAFLD), using an oat fiber drinking supplement. Our triple-blinded RCT compares the metabolic effects and mechanistic outcomes of isocaloric treatments with 15 grams of oat-fiber supplement per day (vs. placebo) in 92 patients, covering an intervention period of 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, NAFLD
Keywords
insoluble cereal fiber, insulin resistance, glucose tolerance, inflammation, incretins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel-designed triple-blinded randomised placebo-controlled intervention study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
blinding applies to participants, study personnel and statistician
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supplementation with insoluble cereal fiber
Arm Type
Active Comparator
Arm Description
Drinking powder supplement providing 7,5 grams of insoluble fiber per sachet, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity
Arm Title
Supplementation with placebo
Arm Type
Placebo Comparator
Arm Description
Drinking powder supplement providing no insoluble fiber, but maltodextrin, taken twice daily over a period of 12 weeks without any changes in dietary behavior, caloric intake or physical activity
Intervention Type
Dietary Supplement
Intervention Name(s)
Drinking powder supplement
Intervention Description
Drinking powder supplement, to be taken twice daily over 12 weeks
Primary Outcome Measure Information:
Title
change in liver fat content (MRS)
Description
change in liver fat content (MRS)
Time Frame
12 weeks
Title
change in glucose tolerance (mixed-meal test)
Description
change in glucose tolerance (mixed-meal test)
Time Frame
12 weeks
Title
change in insulin resistance (Matsuda)
Description
change in insulin resistance (Matsuda)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change in fasting glucose
Description
change in fasting glucose
Time Frame
12 weeks
Title
change in HbA1c
Description
change in HbA1c
Time Frame
12 weeks
Title
change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22
Description
change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22
Time Frame
12 weeks
Title
change in incretins (GLP-1, GIP, PYY)
Description
change in incretins (GLP-1, GIP, PYY)
Time Frame
12 weeks
Title
change in FGF21
Description
change in FGF21
Time Frame
12 weeks
Title
change in IGF-1 and its binding proteins
Description
change in IGF-1 and its binding proteins
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)
Description
change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)
Time Frame
12 weeks
Title
change in fasting serum amino acid pattern
Description
change in fasting serum amino acid pattern
Time Frame
12 weeks
Title
change in faecal excretion of BCAA metabolites
Description
change in faecal excretion of BCAA metabolites
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes mellitus HOMA-IR > 2.5 NAFLD (MR-S > 5,56 %) Exclusion Criteria: insulin treatment diabetes type 1, 3 or 4 severe cardiopulmonary, renal, inflammatory, gastrointestinal, psychiatric or endocrine disorder alcohol abuse or excess alcohol intake recent CVD event (< 3months) relevant liver disease other than NAFLD current cancer diagnosis or treatment allergy or incompatibility to the supplement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Kabisch, Dr. med.
Phone
0049-30-450514429
Email
stefan.kabisch@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmin Hajir, cand.med.
Phone
0049-30-450514428
Email
jasmin.hajir@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Kabisch, Dr. med.
Organizational Affiliation
Study physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Hospital Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kabisch, Dr. med.
Phone
030 450 514 429
Email
stefan.kabisch@charite.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nutraceutical Improvement of Glucose Metabolism, NAFLD and Insulin Resistance by Oat-fiber Supplementation in Type 2 Diabetes Mellitus Patients

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