Clinical trial NCT02281253: Effects of a Bakery Product Enriched With Fibre and L-carnitine on Insulin Resistance in Patients With Metabolic Syndrome
Official title: Evaluation of a Bakery Product Enriched With Fibre and L-carnitine on Cardiovascular Risk Parameters in Patients With Metabolic Syndrome: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic X Syndrome
Overweight
Dyslipidemias
Keywords: L-carnitine
fibre
bakery product
insulin resistance
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: AINIATechnology Center
First posted: 2014-11-02
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients with or without metabolic syndrome.

Detailed description: 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. According to this, both compounds -L-carnitine and dietary fiber- interacting by different mechanism of action could improve glucose homeostasis and insulin sensitivity. However, the health beneficial effects of the combination of both compounds are not shown and confirmation of the functionality of such products must be accomplished by conducting the appropriate studies intervention nutrition.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 35 Kg/m2

Exclusion Criteria:

* Pregnancy or lactation
* Kidney, liver and thyroid disease
* History of cardiovascular or chronic inflammatory disease
* Diabetes mellitus
* Lipid-lowering medication
* Triglyceride concentration \> 400 mg/dl
* Consumption of other carnitine and/or fibre-enriched foods

Primary outcomes:
measure: To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: To evaluate changes in lipid parameters before and after fibre+carnitine/placebo administration
timeFrame: baseline and 12 weeks
measure: To evaluate changes in a composite measure of inflammatory parameters before and after fibre+carnitine/placebo administration
timeFrame: baseline and 12 weeks
Other outcomes:
measure: To assess adverse reactions after fibre+carnitine/placebo administration
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: FISABIO - University Hospital Dr Peset
name: Antonio Hernández, Phd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ringseis R, Keller J, Eder K. Role of carnitine in the regulation of glucose homeostasis and insulin sensitivity: evidence from in vivo and in vitro studies with carnitine supplementation and carnitine deficiency. Eur J Nutr. 2012 Feb;51(1):1-18. doi: 10.1007/s00394-011-0284-2. Epub 2011 Dec 2.
citation: Malaguarnera M, Vacante M, Avitabile T, Malaguarnera M, Cammalleri L, Motta M. L-Carnitine supplementation reduces oxidized LDL cholesterol in patients with diabetes. Am J Clin Nutr. 2009 Jan;89(1):71-6. doi: 10.3945/ajcn.2008.26251. Epub 2008 Dec 3.
citation: Sola R, Bruckert E, Valls RM, Narejos S, Luque X, Castro-Cabezas M, Domenech G, Torres F, Heras M, Farres X, Vaquer JV, Martinez JM, Almaraz MC, Anguera A. Soluble fibre (Plantago ovata husk) reduces plasma low-density lipoprotein (LDL) cholesterol, triglycerides, insulin, oxidised LDL and systolic blood pressure in hypercholesterolaemic patients: A randomised trial. Atherosclerosis. 2010 Aug;211(2):630-7. doi: 10.1016/j.atherosclerosis.2010.03.010. Epub 2010 Mar 17.
citation: Robertson MD, Wright JW, Loizon E, Debard C, Vidal H, Shojaee-Moradie F, Russell-Jones D, Umpleby AM. Insulin-sensitizing effects on muscle and adipose tissue after dietary fiber intake in men and women with metabolic syndrome. J Clin Endocrinol Metab. 2012 Sep;97(9):3326-32. doi: 10.1210/jc.2012-1513. Epub 2012 Jun 28.
citation: Gonzalez-Ortiz M, Hernandez-Gonzalez SO, Hernandez-Salazar E, Martinez-Abundis E. Effect of oral L-carnitine administration on insulin sensitivity and lipid profile in type 2 diabetes mellitus patients. Ann Nutr Metab. 2008;52(4):335-8. doi: 10.1159/000151488. Epub 2008 Aug 19.