Effects of a Bakery Product Enriched With Fibre and L-carnitine on Insulin Resistance in Patients With Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT02281253 |
Recruitment Status :
Completed
First Posted : November 2, 2014
Last Update Posted : November 2, 2014
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Condition or disease | Intervention/treatment | Phase |
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Metabolic X Syndrome Overweight Dyslipidemias | Dietary Supplement: dietary fibre plus L-carnitine bread Dietary Supplement: Placebo bread | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
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 Start Date : | April 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
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Experimental: With metabolic syndrome
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).
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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. |
Experimental: Without metabolic syndrome
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).
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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. |
- To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration [ Time Frame: 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).
- To evaluate changes in lipid parameters before and after fibre+carnitine/placebo administration [ Time Frame: 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 [ Time Frame: 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
- To assess adverse reactions after fibre+carnitine/placebo administration [ Time Frame: 12 weeks ]Diarrhea, constipation, nausea, belching, flatulence, indigestion and bloating were evaluated

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Ages Eligible for Study: | 25 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281253
Principal Investigator: | Antonio Hernández, Phd, MD | FISABIO - University Hospital Dr Peset |
Responsible Party: | Antonio Hernandez Mijares, PhD, MD, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana |
ClinicalTrials.gov Identifier: | NCT02281253 |
Other Study ID Numbers: |
PAN-CAR-2010-01 |
First Posted: | November 2, 2014 Key Record Dates |
Last Update Posted: | November 2, 2014 |
Last Verified: | October 2014 |
L-carnitine fibre bakery product insulin resistance |
Metabolic Syndrome Insulin Resistance Dyslipidemias Syndrome Overweight Disease |
Pathologic Processes Body Weight Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Lipid Metabolism Disorders |