Plasma Trimethylamine N-oxide Elevation Induced by L-carnitine Supplementation and Insulin Resistance
NCT ID: NCT05251207
Last Updated: 2025-10-03
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2022-02-07
2027-05-31
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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carnitine
2 grams of L-carnitine per day for 12 weeks
L-carnitine
L-carnitine-L-tartrate
Change of the circadian cycle
Reducing sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00)
leucine
2 grams of L-leucine per day for 12 weeks
L-leucine
L-leucine
Change of the circadian cycle
Reducing sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00)
modified circadian cycle
no sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00).
L-carnitine
L-carnitine-L-tartrate
L-leucine
L-leucine
normal circadian cycle
sleep at night for four consecutive days
L-carnitine
L-carnitine-L-tartrate
L-leucine
L-leucine
Interventions
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L-carnitine
L-carnitine-L-tartrate
L-leucine
L-leucine
Change of the circadian cycle
Reducing sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00)
Eligibility Criteria
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Inclusion Criteria
* must be able to swallow tablets
Exclusion Criteria
* cardiovascular disease
* liver disease
* kidney disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
20 Years
30 Years
ALL
Yes
Sponsors
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Poznan University of Physical Education
OTHER
Responsible Party
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Robert Olek
Principal Investigator
Principal Investigators
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Robert Olek, PhD
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Physical Education
Locations
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Akademia Wychowania Fizycznego
Poznan, , Poland
Countries
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References
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Samulak JJ, Sawicka AK, Hartmane D, Grinberga S, Pugovics O, Lysiak-Szydlowska W, Olek RA. L-Carnitine Supplementation Increases Trimethylamine-N-Oxide but not Markers of Atherosclerosis in Healthy Aged Women. Ann Nutr Metab. 2019;74(1):11-17. doi: 10.1159/000495037. Epub 2018 Nov 28.
Bescos R, Boden MJ, Jackson ML, Trewin AJ, Marin EC, Levinger I, Garnham A, Hiam DS, Falcao-Tebas F, Conte F, Owens JA, Kennaway DJ, McConell GK. Four days of simulated shift work reduces insulin sensitivity in humans. Acta Physiol (Oxf). 2018 Jun;223(2):e13039. doi: 10.1111/apha.13039. Epub 2018 Feb 12.
Other Identifiers
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2020/39/O/NZ7/01790
Identifier Type: -
Identifier Source: org_study_id
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