Evaluation of novel topical niacin nutriceuticals for improving gut microbiota and metabolic health

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016344

Enrollment

Registered

2019-01-08

Start date

2015-06-10

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

R73.0

Interventions

Group 1: For part A) nicotinic acid 30 mg free-1 day

nicotinic acid 30 mg microencapsulated-1 day

nicotinic acid 150 mg microencapsulated-1 day

nicotinic acid 300 mg miccroencapsulated-1day. Interventions days were separated by one week, resulting in a total study duration (part A) of 4 weeks. For part B) nicotinic acid 30 mg free for 4 days

nicotinic acid 30 mg microencapsulated for 4 days (Monday-Thursday)

nicotinic acid 60 mg microencapsulated for 4 days (Monday-Thursday)

nicotinic acid 90 mg microencapsulated for 4 days (Monday-Thursday)

nicotinic acid 195 mg microencapsulated for 4 days (Monday-Thursday)

nicotinic acid 300 mg microencapsulated for 4 days (Monday-Thursday). This results in a total study duration (part B) of 6 weeks. Group 2: For part A) nicotinamide 900 mg free-1 day

nicotinamide 900 mg microencapsulated-1 day

nicotinamide 1500 mg microencapsulated-1 day

nicotinamide 3000 mg miccroencapsulated-1day. Interventions days were separated by one week, resulting in a total study duration (part A) of 4 weeks. For part B) nicotinamide 900 mg free for 4 days (

nicotinamide 900 mg microencapsulated for 4 days (Monday-Thursday)

nicotinamide 1200 mg microencapsulated for 4 days (Monday-Thursday)

nicotinamide 1500 mg microencapsulated for 4 days (Monday-Thursday)

nicotinamide 2250 mg microencapsulated for 4 days (Monday-Thursday)

nicotinamide 3000 mg microencapsulated for 4 days (Monday-Thursday). This results in a total study duration (part B) of 6 weeks.

Eligibility

Sex/Gender

All

Age

19 Years to 65 Years

Inclusion criteria

Inclusion criteria: Non-Smokers betweenn 19 and 65 years with normal liver- and kidney function.

Exclusion criteria

Exclusion criteria: Exclusion criteria are pregnancy, rheumatic or infectiological diseases (e.g. rheumatism or chronic viral hepatitis), drug use, excessive consumption of alcohol, intake of supplements (e.g. multivitmain or trace elements) and intake of protein shakes (e.g. Almased and BCM). [Further, probands should not take any medication (exception: birth control pill or thyroid hormones)].

Design outcomes

Primary

Measure	Time frame
microbiome change [measured by 16S RNA gene sequencing before dosing and at the end of each dose week 1-6 (part (b))] and safety [routine laboratory analyses (hematological, liver and kindey parameters) before dosing and at the end of each dose week 1-6 (b)] and niacin serum levels [measured by LC-MS/MS (part (a)) at baseline and 1-8 hours as wells as 10 and 12 hours after dosing]	—

Secondary

Measure	Time frame
insulin sensitivity [The biomarkers myotstain, fetuin-A and osteopontin were measured at the beginning and end of each dose week by enzyme-linked immunosorbant assay]	—

Countries

Germany

Contacts

Public ContactKathrin Türk

Schleswig-Holstein Exzellenz Lehrstuhl für Innere Medizin - Endokrinologie, Diabetologie und klinische ErnährungsmedizinKlinik für Innere Medizin 1 des Universitätsklinikums Schleswig-Holstein

kathrin.tuerk@uksh.de0431 500 22453

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026