Dyslipidemias, Metabolic X Syndrome, Overweight
Conditions
Keywords
L-carnitine, fibre, bakery product, insulin resistance
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.
Interventions
DIETARY_SUPPLEMENTdietary 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_SUPPLEMENTPlacebo 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.
Sponsors
AINIATechnology Center
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration | baseline and 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate changes in lipid parameters before and after fibre+carnitine/placebo administration | baseline and 12 weeks | 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. |
| To evaluate changes in a composite measure of inflammatory parameters before and after fibre+carnitine/placebo administration | baseline and 12 weeks | 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-α (TNF-α) were analysed using a flow analyser system |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess adverse reactions after fibre+carnitine/placebo administration | 12 weeks | Diarrhea, constipation, nausea, belching, flatulence, indigestion and bloating were evaluated |
Outcome results
None listed