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

Poznan University of Physical Education

Status: Active, not recruiting

Conditions: Insulin Resistance

Treatments: Dietary Supplement: L-carnitine; Dietary Supplement: L-leucine; Behavioral: Change of the circadian cycle

Study type: Interventional

Funder types: Other

Identifiers

NCT05251207

2020/39/O/NZ7/01790

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

carnitine

Experimental group

Description:

2 grams of L-carnitine per day for 12 weeks

Treatment:

Behavioral: Change of the circadian cycle

Dietary Supplement: L-carnitine

leucine

Placebo Comparator group

Description:

2 grams of L-leucine per day for 12 weeks

Treatment:

Behavioral: Change of the circadian cycle

Dietary Supplement: L-leucine

modified circadian cycle

Experimental group

Description:

no sleep at night for four consecutive days (enabling sleep between 8:00 and 17:00).

Treatment:

Dietary Supplement: L-leucine

Dietary Supplement: L-carnitine

normal circadian cycle

Active Comparator group

Description:

sleep at night for four consecutive days

Treatment:

Dietary Supplement: L-leucine

Dietary Supplement: L-carnitine