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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281253
• Other study ID #: PAN-CAR-2010-01
• Status: Completed
• Phase: N/A
• First received: October 28, 2014
• Last updated: October 30, 2014
• Start date: April 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2014
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemias
• Insulin Resistance
• Metabolic Syndrome X
• Metabolic X Syndrome
• Overweight
• Syndrome

Intervention

Dietary Supplement:
• dietary fibre plus L-carnitine bread
The enriched bread consisted of a mix of wheat flour, vegetable flour, rye flour, wheat gluten, soy protein, soluble and insoluble dietary fibre, inulin, guar gum, L-carnitine salt, diacetyl tartaric, enzymes, ascorbic acid, water and yeast. Patients were recommended to consume the bread twice per day with main meals.
• Placebo bread
The placebo group received commercially available bread with a similar macronutrient composition and energy intake to that consumed by the enriched bread group but without L-carnitine and dietary fibre. Patients were recommended to consume the bread twice per day with main meals.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana	AINIATechnology Center

References & Publications (5)

González-Ortiz M, Hernández-González SO, Hernández-Salazar E, Martínez-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. — View 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. — View 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. Review. — View 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. — View Citation

Solà R, Bruckert E, Valls RM, Narejos S, Luque X, Castro-Cabezas M, Doménech G, Torres F, Heras M, Farrés X, Vaquer JV, Martínez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess adverse reactions after fibre+carnitine/placebo administration	Diarrhea, constipation, nausea, belching, flatulence, indigestion and bloating were evaluated	12 weeks	Yes
Primary	To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration	Blood samples were collected in vacutainer serum separator tubes, after 12-hour overnight fasting, to analyze glucose, insulin and C-peptide concentration at baseline (after a four weeks run-in period of a healthy diet), and 12 weeks after fibre+carnitine/placebo administration.; Glucose was determined using enzymatic techniques and insulin and C-peptide were measured by an enzymatic luminescence technique in an autoanalyzer. Insulin resistance was calculated by homeostasis model assessment (HOMA = (fasting insulin (µU/mL×) fasting glucose (mg/dl)/405).	baseline and 12 weeks	Yes
Secondary	To evaluate changes in lipid parameters before and after fibre+carnitine/placebo administration	Blood samples were collected in vacutainer serum separator tubes, after 12-hour overnight fasting, to analyze lipid profile at baseline (after a four weeks run-in period of a healthy diet), and 12 weeks after fibre+carnitine/placebo administration. Total cholesterol and triglycerides were measured by means of enzymatic assays, and high-density lipoproteins (HDL) concentrations were recorded with an autoanalyzer using a direct method. Low-density lipoprotein (LDL) concentration was calculated using the method of Friedewald. Non-HDL concentration was obtained by calculating the difference between total cholesterol and HDL. LDL subfractions were separated by high-resolution polyacrylamide gel tubes. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.	baseline and 12 weeks	Yes
Secondary	To evaluate changes in a composite measure of inflammatory parameters before and after fibre+carnitine/placebo administration	Blood samples were collected in vacutainer serum separator tubes, after 12-hour overnight fasting, to analyze inflammatory markers at baseline (after a four weeks run-in period of a healthy diet), and 12 weeks after fibre+carnitine/placebo administration. Levels of high-sensitive C-reactive protein (hsCRP) and proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor-a (TNF-a) were analysed using a flow analyser system	baseline and 12 weeks	Yes