- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281253
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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.
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).
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and 12 weeks
|
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
|
baseline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess adverse reactions after fibre+carnitine/placebo administration
Time Frame: 12 weeks
|
Diarrhea, constipation, nausea, belching, flatulence, indigestion and bloating were evaluated
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Antonio Hernández, Phd, MD, FISABIO - University Hospital Dr Peset
Publications and helpful links
General Publications
- 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.
- 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.
- Sola R, Bruckert E, Valls RM, Narejos S, Luque X, Castro-Cabezas M, Domenech G, Torres F, Heras M, Farres X, Vaquer JV, Martinez 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.
- 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.
- Gonzalez-Ortiz M, Hernandez-Gonzalez SO, Hernandez-Salazar E, Martinez-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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAN-CAR-2010-01
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