NCT05251207

Plasma Trimethylamine N-oxide Elevation Induced by L-carnitine Supplementation and Insulin Resistance

The Role of Gut Microbiota Metabolite, Trimethylamine N-oxide, in the Insulin Resistance Development

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Poznan University of Physical Education · Academic / Other
• Sex: All
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The primary aims of the current study: * using L-carnitine supplementation modulate the level of plasma trimethylamine N-oxide to assess its effect on circulating cytokines related to diabetes and metabolic syndrome; * using simulated night-shift work intervention as a stress factor, explore the effect of circulating metabolites on insulin sensitivity The secondary aim is to evaluate the effect of carnitine supplementation on gut microbiome composition.

Detailed description

Subjects will be randomly divided in two groups: supplemented by L-carnitine 2g/day for 12 weeks, and placebo group receiving leucine in identical gelatine capsules. Subjects who successfully complete the protocol will be divided into four subgroups - two with a changed circadian cycle and two controls (supplemented and placebo). Subgroups with a changed daily cycle will be able to sleep between 8:00 and 17:00 for four consecutive days, while during the night they will stay active in the laboratory. The oral glucose tolerance test (OGTT) will be performed before and after the circadian cycle modification. Glucose levels will be monitored by FreeStyle Libre Sensor. Moreover, the activity of the participants will be monitored by wearable activity trackers. Before supplementation, as well as before circadian cycle modification and after finishing the whole experimental procedure, fasting blood samples will be collected for determination of plasma trimethylamine N-oxide (TMAO), trimethylamine (TMA), carnitine (free and acyl derivatives), protein markers of diabetes and inflammation. Moreover, the stool samples will be collected before and after 12 weeks of supplementation, to determine the composition of the gut microbiome. In addition diet of participants will be monitored.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-carnitine	L-carnitine-L-tartrate
DIETARY_SUPPLEMENT	L-leucine	L-leucine
BEHAVIORAL	Change of the circadian cycle	Reducing sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00)

Timeline

• Start date: 2022-02-07
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2022-02-22
• Last updated: 2025-10-03

Locations

1 site across 1 country: Poland