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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05654805
Acronym
NIMROD
Enrollment
92
Registered
2022-12-16
Start date
2022-12-15
Completion date
2024-10-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, Type 2 Diabetes

Keywords

insoluble cereal fiber, insulin resistance, glucose tolerance, inflammation, incretins

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.

Interventions

DIETARY_SUPPLEMENTDrinking powder supplement

Drinking powder supplement, to be taken twice daily over 12 weeks

Sponsors

Wilhelm-Doerenkamp-Foundation (Funding)
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

blinding applies to participants, study personnel and statistician

Intervention model description

parallel-designed triple-blinded randomised placebo-controlled intervention study

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in liver fat content (MRS)12 weekschange in liver fat content (MRS)
change in glucose tolerance (mixed-meal test)12 weekschange in glucose tolerance (mixed-meal test)
change in insulin resistance (Matsuda)12 weekschange in insulin resistance (Matsuda)

Secondary

MeasureTime frameDescription
change in IGF-1 and its binding proteins12 weekschange in IGF-1 and its binding proteins
change in fasting glucose12 weekschange in fasting glucose
change in HbA1c12 weekschange in HbA1c
change in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-2212 weekschange in inflammation parameters (CRP, leucocytes, IL-6, IL-1ß, IL-18, IL-10, IL-22
change in incretins (GLP-1, GIP, PYY)12 weekschange in incretins (GLP-1, GIP, PYY)
change in FGF2112 weekschange in FGF21

Other

MeasureTime frameDescription
change in fasting serum amino acid pattern12 weekschange in fasting serum amino acid pattern
change in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)12 weekschange in secondary GI peptide hormons (GLP-2, PP, ghrelin, CCK)
change in faecal excretion of BCAA metabolites12 weekschange in faecal excretion of BCAA metabolites

Countries

Germany

Contacts

Primary ContactStefan Kabisch, Dr. med.
stefan.kabisch@charite.de0049-30-450514429
Backup ContactJasmin Hajir, cand.med.
jasmin.hajir@charite.de0049-30-450514428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026