Double blind randomized clinical trial controlled by placebo with an alphalinoleic acid and prebiotic enriched cookie on risk cardiovascular factor in obese patients / Ensayo clínico aletorizado doble ciego controlado con placebo con una galleta enriquecida en ácido alfa linoleico y prebióticos en el patrón de riesgo cardiovascular de pacientes obesos

Introduction: Inulin and FOS are prebiotics with potential benefit in cardiovascular risk factors. Alphalinolenic acid (ALA) is the metabolic precursor of the long chain n-3 fatty acid eicosapentaenoic acid (20: 5n-3),this fatty acid has anti-inflammatory properties. The aim of our study was to evaluate the response of the cardiovascular risk profile in obese patients after inclusion in the diet of an ALA, FOS and inulin enriched-cookie. Material and methods: 36 patients were randomized in both branches: group I (inulin, FOS and ALA enriched cookie) Gullon SL® and group II (control cookie). Previous and after 1 month of the treatment, a nutritional and biochemical study was realized. Results: 15 patients finished the procotol in each group. In group I, a significantly increase in soluble fiber (2.3 ±0.8 g/day vs 7.7 ± 0.8 g/day: p < 0.05) and ALA (0.6 ± 0.5g/day vs 3.8 ± 0.5 g/day; p < 0.05) intakes was detected. In this group a significant decrease of total cholesterol (238.1± 45.3 mg/dl vs 210.5 ± 38.1 mg/dl: p < 0.05), LDL cholesterol(153.6 ± 23.2 mg/dl vs 127.1 ± 27.9 mg/dl: p < 0.05)and C reactive protein (6.6 ± 1.4 mg/dl vs 4.4+7-1.8 mg/dl:p < 0.05) was reached in males. Anthropometric parameters did not change in both groups. The increase in soluble fiber and ALA dietary intakes did not produce any gastrointestinal adverse effect. Conclusion: The increase of 2 grams per day of inulin,3.1 grams per day of FOS and 3.2 grams per day of alphalinolenic (ALA) dietary intakes from an enriched-cookie, improved total cholesterol, LDL cholesterol and C reactive protein levels in obese males. As far as we know, this is the first study that has evaluated the effect on risk factors of an ALA enriched cookies (AU)

Introducción: La inulina y los FOS son prebióticos con potenciales efectos beneficiosos a nivel cardiovascular. El acido alfa linolénico (ALA) es el precursor del ácido eicosapentaenoico (20: 5n-3), presentando propiedades antinflamatorias. El objetivo de nuestro trabajo es evaluar la respuesta del perfil de riesgo cardiovascular en pacientes obesos tras la inclusión en la dieta de una galleta enriquecida en inulina, FOS y ALA. Material y métodos: Un total de 36 pacientes fueron randomizados a una de las siguientes ramas: galleta I(enriquecida con inulina, FOS y ALA) y galleta II (galleta control) (Gullón SL). Cada paciente recibió un total de 2 galletas al día (70 gramos de producto). Antes de iniciar el tratamiento y al mes, se realizó una valoración nutricional y analítica. Resultados: Finalizaron el protocolo un total de 15 pacientes en cada grupo. En el grupo I se produjo un aumento significativo en la ingesta de fibra soluble (2,3 ±0,8 g/día vs 7,7 ± 0,8 g/día: p < 0,05) (inulina y FOS), así como ALA (0,6 ± 0,5 g/día vs 3,8 ± 0,5 g/día; p < 0,05). Se detectó en los pacientes varones que recibieron las galletas enriquecidas una disminución significativa de los niveles de colesterol total (238,1 ± 45,3 mg/dl vs 210,5 ±38,1 mg/dl: p < 0,05), LDL colesterol (153,6 ± 23,2 mg/dlvs 127,1 ± 27,9 mg/dl: p < 0,05) y proteína C reactiva (6,6 ±1,4 mg/dl vs 4,4+7-1,8 mg/dl: p < 0,05). No existieron diferencias estadísticamente significativas en las variables antropométricas. El aumento de la ingesta dietética de fibra soluble y ALA en los pacientes de grupo I no supuso ningún efecto secundario a nivel gastrointestinal. Conclusión: El aumento en la ingesta con una galleta enriquecida de 2 gramos al día de inulina, 3,1 gramos de FOS y 3,2 gramos de ALA, mejora en los pacientes obesos varones los niveles de colesterol total, LDL colesterol y proteína C reactiva (AU)

Double blind randomized clinical trial controlled by placebo with an alpha linoleic acid and prebiotic enriched cookie on risk cardiovascular factor in obese patients.

INTRODUCTION: Inulin and FOS are prebiotics with potential benefit in cardiovascular risk factors. Alpha linolenic acid (ALA) is the metabolic precursor of the long chain n-3 fatty acid eicosapentaenoic acid (20: 5n-3), this fatty acid has anti-inflammatory properties. The aim of our study was to evaluate the response of the cardiovascular risk profile in obese patients after inclusion in the diet of an ALA, FOS and inulin enriched-cookie. MATERIAL AND METHODS: 36 patients were randomized in both branches: group I (inulin, FOS and ALA enriched cookie) Gullon SL(®) and group II (control cookie). Previous and after 1 month of the treatment, a nutritional and biochemical study was realized. RESULTS: 15 patients finished the procotol in each group. In group I, a significantly increase in soluble fiber (2.3 ± 0.8 g/day vs 7.7 ± 0.8 g/day: p < 0.05) and ALA (0.6 ± 0.5 g/day vs 3.8 ± 0.5 g/day; p < 0.05) intakes was detected. In this group a significant decrease of total cholesterol (238.1 ± 45.3 mg/dl vs 210.5 ± 38.1 mg/dl: p < 0.05), LDL cholesterol (153.6 ± 23.2 mg/dl vs 127.1 ± 27.9 mg/dl: p < 0.05) and C reactive protein (6.6 ± 1.4 mg/dl vs 4.4+7-1.8 mg/dl: p < 0.05) was reached in males. Anthropometric parameters did not change in both groups. The increase in soluble fiber and ALA dietary intakes did not produce any gastrointestinal adverse effect. CONCLUSION: The increase of 2 grams per day of inulin, 3.1 grams per day of FOS and 3.2 grams per day of alpha linolenic (ALA) dietary intakes from an enriched-cookie, improved total cholesterol, LDL cholesterol and C reactive protein levels in obese males. As far as we know, this is the first study that has evaluated the effect on risk factors of an ALA enriched cookies.

[Randomized clinical trial with a inulin enriched cookie on risk cardiovascular factor in obese patients]. / Ensayo clínico aleatorizado con una galleta enriquecida en inulina en el patrón de riesgo cardiovascular de pacientes obesos.

INTRODUCTION: Inulin is a prebiotic with potential benefit in cardiovascular risk factors. The aim of our work is to evaluate in obese patients the effect of a inulin enriched cookie on cardiovascular risk factors. MATERIAL AND METHODS: 34 patients were randomized in both branches: group I (inulin enriched cookie) Gullon SL(R) and group II (control cookie). Previous and after 1 month of the treatment, a nutritional and biochemical study was realized. RESULTS: 15 patients finished the procotol in each group. In group I, an increase in soluble fiber intake (inulin) was detected. In this group a significant decrease of total cholesterol (223.1 +/- 45.3 mg/dl vs 208.8 +/- 33.1 mg/dl; p < 0.05) and LDL cholesterol (142.9 +/- 39.2 mg/dl vs 131.4 +/- 28.6 mg/dl; p < 0.05) was reached. A non significant improvement in insulin levels and HOMA was detected in inulin-enriched cookie group, too. Anthropometric parameters did not change in both groups. The increase in soluble fiber intake did not produce any gastrointestinal adverse effect. CONCLUSION: The increase of fiber intake (3 g of inulin) from an enriched cookie reduced LDL cholesterol levels in obese patients.

Ensayo clínico aleatorizado con una galleta enriquecida en inulina en el patrón de riesgo cardiovascular de pacientes obesos / Randomized cinical trial with a inulin enriched cookie on cardiovascular risk factor in obese patients

Introducción: La inulina es un prebiótico con potenciales efectos beneficiosos a nivel cardiovascular. El objetivo de nuestro trabajo es evaluar la respuesta del perfil de riesgo cardiovascular en pacientes obesos tras la inclusión en la dieta de una galleta enriquecida en inulina. Material y métodos: Un total de 34 pacientes fueron randomizados a una de las siguientes ramas: galleta I (enriquecida con inulina, ver tabla I) y galleta II (galleta control, ver tabla I) (Gullón SL). Cada paciente recibió un total de 8 galletas al día (total de 68 gramos de producto). Antes de iniciar el tratamiento y al mes se realizóuna valoración nutricional y analítica. Resultados: Finalizaron un total de 15 pacientes en cada grupo. En el grupo I se produjo un aumento significativo en la ingesta de fibra soluble (inulina). Se detectó en los pacientes con las galletas enriquecidas en inulina una disminución significativa de los niveles de colesterol total (223,1 ± 45,3 mg/dl vs 208,8 ± 33,1 mg/dl; p < 0,05) y LDL colesterol (142,9 ± 39,2 mg/dl vs 131,4 ± 28,6 mg/dl; p < 0,05). También se detectó una disminución de los niveles de insulina y resistencia a la insulina (HOMA), pero sin alcanzar la significación estadística. No existieron diferencias estadísticamente significativas en las variables antropométricas. El aumento de la ingesta de fibra soluble en los pacientes de grupo I no supuso ningún efecto secundario a nivel gastrointestinal. Conclusión: El aumento en la ingesta de 3 gramos de inulina proveniente de una galleta enriquecida, reduce los niveles de colesterol LDL en pacientes obesos (AU)

Introduction: Inulin is a prebiotic with potential benefit in cardiovascular risk factors. The aim of our work is to evaluate in obese patients the effect of a inulin enriched cookie on cardiovascular risk factors. Material and methods: 34 patients were randomized in both branches: group I (inulin enriched cookie) Gullon SL® and group II (control cookie). Previous and after 1 month of the treatment, a nutritional and biochemical study was realized. Results: 15 patients finished the procotol in each group. In group I, an increase in soluble fiber intake (inulin) was detected. In this group a significant decrease of total cholesterol (223.1 ± 45.3 mg/dl vs 208.8 ± 33.1 mg/dl; p < 0.05) and LDL cholesterol (142.9 ± 39.2 mg/dl vs 131.4 ± 28.6 mg/dl; p < 0.05) was reached. A non significant improvement in insulin levels and HOMA was detected in inulin-enriched cookie group, too. Anthropometric parameters did not change in both groups. The increase in soluble fiber intake did not produce any gastrointestinal adverse effect. Conclusion: The increase of fiber intake (3 g of inulin) from an enriched cookie reduced LDL cholesterol levels in obese patients (AU)