Effects of a Bakery Product Enriched With Fibre and L-carnitine on Insulin Resistance in Patients With Metabolic Syndrome

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine for insulin resistance, prediabetes & type 2 diabetes.

It had two arms (groups): With metabolic syndrome (experimental) and Without metabolic syndrome (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

Conceivably, different biochemical changes in insulin-mediated signalling pathways may contribute to an impaired insulin-mediated glucose transport and metabolism that eventually results in insulin resistance and the clinical features of metabolic syndrome.

Who Took Part

54 actual participants took part.

It was open to people of any sex aged from 25 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI between 25 and 35 Kg/m2.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: pregnancy or lactation; kidney, liver and thyroid disease; history of cardiovascular or chronic inflammatory disease.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-04 with completion listed for 2012-07.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration (time frame: baseline and 12 weeks).

It also tracked 2 secondary outcomes, for example To evaluate changes in lipid parameters before and after fibre+carnitine/placebo administration and To evaluate changes in a composite measure of inflammatory parameters before and after fibre+carnitine/placebo administration.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 54 people with insulin resistance, prediabetes & type 2 diabetes.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Insulin resistance, prediabetes & type 2 diabetes research.