Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

Quick Stats
Studies 458
Trials 82
Active Not Recruiting NA INTERVENTIONAL NCT05251207

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Circulating microbiome metabolites
TimeFrame: 13 weeks
Description: Determination of plasma trimethylamine and trimethylamine N-oxide using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method
Measure: Circulating carnitine metabolites
TimeFrame: 13 weeks
Description: Determination of plasma free, total, and acyl-L-carnitines using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method
Measure: Circulating diabetes biomarkers
TimeFrame: 13 weeks
Description: insulin, C-peptide, ghrelin, leptin, resistin using enzyme-linked immunosorbent assay
Measure: Circulating inflammatory biomarkers
TimeFrame: 13 weeks
Description: tumor necrosis factor, C-reactive protein using enzyme-linked immunosorbent assay
Measure: Oral Glucose Tolerance Test
TimeFrame: 1 week
Description: The subjects will consume 75 g of glucose solution drink within a 5-minute time frame. The glucose level will be continuously monitored with the FreeStyle Libre Sensor.

Trial Information

NCT ID

NCT05251207

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Poznan University of Physical Education

Last Updated

December 15, 2025