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

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Completed

Conditions: Metabolic X Syndrome; Overweight; Dyslipidemias

Treatments: Dietary Supplement: dietary fibre plus L-carnitine bread; Dietary Supplement: Placebo bread

Study type: Interventional

Funder types: Other

Identifiers

NCT02281253

PAN-CAR-2010-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

With metabolic syndrome

Experimental group

Description:

Before dietary therapy was initiated, in order to stabilise dietary patterns prior to intervention, patients were submitted to a 4-weeks run-in period of a caloric restriction of 500 Kcal to their usual diet. After this adaptation period, two intervention groups were evaluated: a calorie-restricted diet plus bread-enriched product that received 15.08 g of dietary fibre (9.49 g of insoluble fibre and 5.59 g of soluble fibre) plus 2325 mg of L-carnitine/day in 130 g of bread (enriched group) and a calorie-restricted diet plus placebo bread group whose diet included 130 g/day of not-enriched bread (placebo group).

Treatment:

Dietary Supplement: dietary fibre plus L-carnitine bread

Dietary Supplement: Placebo bread

Without metabolic syndrome

Experimental group

Description:

Before dietary therapy was initiated, in order to stabilise dietary patterns prior to intervention, patients were submitted to a 4-weeks run-in period of a caloric restriction of 500 Kcal to their usual diet. After this adaptation period, two intervention groups were evaluated: a calorie-restricted diet plus bread-enriched product that received 15.08 g of dietary fibre (9.49 g of insoluble fibre and 5.59 g of soluble fibre) plus 2325 mg of L-carnitine/day in 130 g of bread (enriched group) and a calorie-restricted diet plus placebo bread group whose diet included 130 g/day of not-enriched bread (placebo group).

Treatment:

Dietary Supplement: dietary fibre plus L-carnitine bread

Dietary Supplement: Placebo bread