Trial | NCT02281253  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fiber levocarnitine ...

  • Study Participants

    54
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.
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.
Study Started
Apr 30
2010
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Nov 02
2014
Estimate

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.

Dietary Supplement 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.

With metabolic syndrome Experimental

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).

Without metabolic syndrome Experimental

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).

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
No Results Posted