Intestinal imidazole propioNaTE productioN after histiDinE supplementation in healthy and type 2 Diabetes mellitus subjects: role of the gut microbiota; INTENDED-study

Intestinal imidazole propioNaTE productioN after histiDinE supplementation in healthy and type 2 Diabetes mellitus subjects: role of the gut microbiota; INTENDED-study - INTENDED

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54977

Enrollment

Registered

2020-02-07

Start date

2020-05-28

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

diabetes mellitus sugar disease

Interventions

We will orally administrate 4g of the food supplement histidine (Vital Cell Life L-Histidine 500 MG Capsules 100CP) once a day for 7 weeks, after the first 2 weeks, one week of antibiotics will be a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy subjects: (n=11 Caucasian and n=11 from South Asian Surinamese descent) - Healthy subjects 40-70 years, - BMI 19-25 T2D subjects:(n=11 Caucasian and n=11 from South Asian Surinamese descent) - T2D patients - Caucasian / South Asian Surinamese - 40-70 years - BMI 25-35 - Stable anti-diabetic drugs for 3 months (metformin is obligatory) - Statin use - Stable medication use past 3 months - Able to give informed consent

Exclusion criteria

Exclusion criteria: All participants: - Previous major cardiovascular event (e.g. AMI/stroke/TIA) - Proton-pomp inhibitor use - GLP1 or insulin - Antibiotics use for the past 3 months - Probiotic of symbiotic usage - Pregnant women, - Chronic illness (including a known history of heart failure, renal failure (eGFR 6 alcohol units per day or >14 alcohol units per week - Active malignancy - HbA1c >9% (75mmol/mol) - The subject is already involved in a clinical trial

Design outcomes

Primary

Measure	Time frame
Primary objective will be determination of ImP levels after histidine intake and other degradation products such as urocanate and glutamate before and after oral antibiotics.	—

Secondary

Measure	Time frame
Secondary objectives will be differences in histidine uptake effect upon oral histidine supplementation on PBMC inflammatory status, influence of gut microbiome on ImP production, continuous (freestyle libre) as well as postprandial (after a mixed meal test) glucose levels between healthy and T2D subjects on stable dose of oral metformin. Furthermore, we will evalualte if the kinetics and other mentioned parameters are affected differently between ethnicities by histidine intake.	—

Measure

Time frame

Secondary objectives will be differences in histidine uptake effect upon oral histidine supplementation on PBMC inflammatory status, influence of gut microbiome on ImP production, continuous (freestyle libre) as well as postprandial (after a mixed meal test) glucose levels between healthy and T2D subjects on stable dose of oral metformin. Furthermore, we will evalualte if the kinetics and other mentioned parameters are affected differently between ethnicities by histidine intake.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026