The Role of Gut Microbiota Metabolite, Trimethylamine N-oxide, in the Insulin Resistance Development
| Registry | NCT05251207, acronym MR |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 40 (Actual) |
| Sponsor | Poznan University of Physical Education (Other) |
| Conditions | Insulin Resistance |
| Interventions | L-carnitine, L-leucine, Change of the circadian cycle (Dietary supplement, behavioral) |
| Dates | start 2022-02-07, primary completion 2026-05-31, completion 2026-08-13, first posted 2022-02-22, last updated 2026-08-17 |
| Locations | 1 site in Poland |
Related Papers Related Patents Related Grants Related Experts
All trials for Insulin Resistance All trials of L-carnitine All trials of L-leucine
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| carnitine | Experimental | Dietary Supplement: L-carnitine; Behavioral: Change of the circadian cycle | 2 grams of L-carnitine per day for 12 weeks |
| leucine | Placebo comparator | Dietary Supplement: L-leucine; Behavioral: Change of the circadian cycle | 2 grams of L-leucine per day for 12 weeks |
| modified circadian cycle | Experimental | Dietary Supplement: L-carnitine; Dietary Supplement: L-leucine | no sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00). |
| normal circadian cycle | Active comparator | Dietary Supplement: L-carnitine; Dietary Supplement: L-leucine | sleep at night for four consecutive days |
Sex: All, ages: 20 Years to 30 Years, accepts healthy volunteers
Inclusion Criteria: * healthy volunteers, * must be able to swallow tablets Exclusion Criteria: * smokers, * cardiovascular disease * liver disease * kidney disease * gastrointestinal disorders (including stomach ulcers and erosions) * diabetes
| Facility | City | Country | Status |
|---|---|---|---|
| Akademia Wychowania Fizycznego | Poznan | Poland |