Evaluación sensorial de un suplemento nutricional oral específico para diabetescon aceite de oliva virgen extra en pacientes en riesgo nutricional y diabetes mellitustipo 2: ensayo clínico doble ciego, aleatorizado, cruzado y multicéntrico (DIACARE) / Organoleptic evaluation of a diabetes-specific oral nutritional supplement with extra virgin olive oil in patients at nutritional risk and type 2 diabetes mellitus: double-blind, randomized, crossover and multicenter clinical trial (DIACARE)

Introducción: las fórmulas nutricionales específicas para diabetes (FED) suelen presentar una composición que favorece simultáneamente su palatabilidad y el control glucémico y metabólico.Objetivo: comparar la aceptación sensorial de un FED respecto a un suplemento nutricional oral estándar (FE) en pacientes en riesgo de desnutrición con diabetes mellitus tipo 2.Método: ensayo clínico, aleatorizado, doble ciego, cruzado, multicéntrico y controlado. Se evaluó, a través de una escala del 1 al 4, el olor, el sabor y la textura percibida de un FED y de un FE.Resultados: se reclutaron a 29 pacientes y 58 evaluaciones sensoriales de los suplementos. Se observó una mejor valoración de la FED respecto a la FE, aunque no se alcanzaron diferencias estadísticamente significativas: olor, 0,04 (IC 95 %), de -0,49 a 0,56 (p = 0,092); sabor, 0,14 (IC 95 %), de -0,35 a 0,63 (p = 0,561); textura, 0,14, (IC 95 %), de -0,43 a 0,72 (p = 0,619). No se encontraron diferencias cuando se analizaron por orden de aleatorización, sexo, grado de desnutrición, mayor o menor grado de complejidad, mayor o menor tiempo de evolución de la diabetes, ni por ser más o menos mayores. Conclusiones: el suplemento nutricional específico para paciente con diabetes, formulado con aceite de oliva virgen extra, EPA y DHA, una mezcla específica en hidratos de carbono, fibra soluble e insoluble, presentó una adecuada aceptación sensorial del paciente desnutrido con diabetes mellitus tipo 2.(AU)

Introduction: oral nutritional supplements specific for diabetes (DSF) usually have a composition that favors their palatability and simultaneous glycemic and metabolic control. Objective: to compare the sensory acceptability of a DSF with respect to a standard oral nutritional supplement (STF) in patients at risk of malnutrition with type 2 diabetes mellitus. Method: randomized, double-blind, crossover, multicenter, controlled, double-blind clinical trial. Odor, taste and perceived texture of a DSF and a STD were evaluated using a scale of 1 to 4. Results: twenty-nine patients were recruited and 58 organoleptic evaluations of the supplements were registered. A better evaluation of DSF was observed with respect to STD, although no statistically significant differences were reached: odor, 0.04 (CI 95 %) -0.49 to 0.56 (p = 0.092); taste, 0.14 (CI 95 %), -0.35 to 0.63 (p = 0.561); texture, 0.14 (CI 95 %), -0.43 to 0.72 (p = 0.619). No differences were found when analyzed by order of randomization, sex, degree of malnutrition, greater or lesser degree of complexity, greater or lesser time of evolution of diabetes, or by being older or younger. Conclusions: the specific nutritional supplement for diabetic patients formulated with extra virgin olive oil, EPA and DHA, a specific mixture of carbohydrates, and fiber, presented an adequate sensory acceptance by malnourished patients with type 2 diabetes mellitus.(AU)

Glycaemic and insulinaemic impact of a diabetes-specific oral nutritional supplement with extra-virgin olive oil in patients with type 2 diabetes mellitus at nutritional risk: a randomized, double-blind, crossover, multicentre clinical trial (DiACARE) / Impacto glucémico e insulinémico de un suplemento nutricional oral con AOVE específico para diabetes en pacientes en riesgo nutricional y con diabetes mellitus tipo 2: ensayo clínico, aleatorizado, doble ciego, cruzado y multicéntrico (DIACARE)

Introduction: there is controversy about the usefulness of specific enteral nutrition formulas in malnourished patients with diabetes. The effects on blood glucose and other aspects of metabolic control are not fully understood in the scientific literature. Objective: the aim of the study was to compare the glycaemic and insulinaemic response of patients with type 2 diabetes at risk of malnutrition after oral feed between a diabetes-specific formula with AOVE (DSF) and a standard one (STF). Methods: A randomized, double-blind, crossover, multicentre clinical trial was conducted in patients with type 2 diabetes at risk of malnutrition (SGA). The patients were randomized to receive either DSF or STF, a week apart. A glycaemia and insulinaemia curve was made at times 0 minutes, 30 min, 60 min, 90 min, 120 min, and 180 min after the patients drank 200 ml of the oral nutritional supplement (ONS). The principal variables were the area under the curve (AUC0-t) of glucose and insulin. Results: 29 patients (51 % women) were included, who were on average 68.84 (SD 11.37) years old. Regarding the degree of malnutrition, 86.2 % presented moderate malnutrition (B) and 13.8 % severe (C). When the patients received the DSF, they had a lower mean of glucose AUC0-t (-3,325.34 mg/min/dl [95 % CI: -4,3608.34 to -2,290.07]; p = 0.016) and also a lower mean of insulin AUC0-t (-451.14 uU/min/ml [95 % CI: -875,10 to -27.17]; p = 0.038). There were no differences in the degree of malnutrition. Conclusion: compared with STF, DSF with AOVE showed a better glycaemic and insulinaemic response in patients with type 2 diabetes at risk of malnutrition.(AU)

Introducción: la utilidad de las fórmulas específicas de nutrición enteral en el paciente desnutrido con diabetes resulta controvertida. Sus efectossobre la glucosa en sangre y otros aspectos del control metabólico no se conocen del todo en la literatura científica.Objetivo: el objetivo del estudio fue comparar la respuesta glucémica e insulinémica de los pacientes con diabetes de tipo 2 (DM2) en riesgode desnutrición tras la ingesta oral de una fórmula específica para diabetes (DSF) con aceite de oliva virgen extra (AOVE) y una estándar (STF).Métodos: ensayo clínico aleatorizado, doble ciego, cruzado y multicéntrico enpacientes con DM2 en riesgo de desnutrición (SGA). Los pacientes seasignaron aleatoriamente para recibir DSF o STF con una semana de diferencia. Se realizó una curva de glucemia e insulinemia en los siguientestiempos: 0 minutos, 30 min, 60 min, 90 min, 120 min y 180 min tras la ingesta de 200 ml del suplemento nutricional oral (SNO). Las variablesprincipales fueron el área bajo la curva (AUC0-t) de glucosa e insulina.Resultados: se incluyeron 29 pacientes (51 % mujeres), con una edad media de 68,84 años (DE 11,37). En cuanto al grado de desnutrición,el 86,2 % presentaba desnutrición moderada (B) y el 13,8 %, severa (C). Cuando los pacientes recibieron DSF tuvieron una media más bajade AUC0-t de glucosa (-3325,34 mg/min/dl [IC 95 %: de -4.3608,34 a -2.290,07]; p = 0,016) y también una media más baja de AUC0-t deinsulina (-451,14 μU/min/ml [IC 95 %: de -875,10 a -27,17]; p = 0,038) respecto a cuando recibieron STF. No hubo diferencias por el gradode desnutrición.Conclusión: la fórmula con AOVE específica para diabetes mostró una mejor respuesta glucémica e insulinémica en pacientes con diabetes detipo 2 en riesgo de desnutrición respecto a una fórmula estándar.(AU)

[Organoleptic evaluation of a diabetes-specific oral nutritional supplement with extra virgin olive oil in patients at nutritional risk and type 2 diabetes mellitus: Double-blind, randomized, crossover and multicenter clinical trial (DIACARE)]. / Evaluación sensorial de un suplemento nutricional oral específico para diabetes con aceite de oliva virgen extra en pacientes en riesgo nutricional y diabetes mellitus tipo 2: ensayo clínico doble ciego, aleatorizado, cruzado y multicéntrico (DIACARE.

Introduction: Introduction: oral nutritional supplements specific for diabetes (DSF) usually have a composition that favors their palatability and simultaneous glycemic and metabolic control. Objetive: to compare the sensory acceptability of a DSF with respect to a standard oral nutritional supplement (STF) in patients at risk of malnutrition with type 2 diabetes mellitus. Method: randomized, double-blind, crossover, multicenter, controlled, double-blind clinical trial. Odor, taste and perceived texture of a DSF and a STD were evaluated using a scale of 1 to 4. Results: twenty-nine patients were recruited and 58 organoleptic evaluations of the supplements were registered. A better evaluation of DSF was observed with respect to STD, although no statistically significant differences were reached: odor, 0.04 (CI 95 %) -0.49 to 0.56 (p = 0.092); taste, 0.14 (CI 95 %), -0.35 to 0.63 (p = 0.561); texture, 0.14 (CI 95 %), -0.43 to 0.72 (p = 0.619). No differences were found when analyzed by order of randomization, sex, degree of malnutrition, greater or lesser degree of complexity, greater or lesser time of evolution of diabetes, or by being older or younger. Conclusions: the specific nutritional supplement for diabetic patients formulated with extra virgin olive oil, EPA and DHA, a specific mixture of carbohydrates, and fiber, presented an adequate sensory acceptance by malnourished patients with type 2 diabetes mellitus.

Introducción: Introducción: las fórmulas nutricionales específicas para diabetes (FED) suelen presentar una composición que favorece simultáneamente su palatabilidad y el control glucémico y metabólico. Objetivo: comparar la aceptación sensorial de un FED respecto a un suplemento nutricional oral estándar (FE) en pacientes en riesgo de desnutrición con diabetes mellitus tipo 2. Método: ensayo clínico, aleatorizado, doble ciego, cruzado, multicéntrico y controlado. Se evaluó, a través de una escala del 1 al 4, el olor, el sabor y la textura percibida de un FED y de un FE. Resultados: se reclutaron a 29 pacientes y 58 evaluaciones sensoriales de los suplementos. Se observó una mejor valoración de la FED respecto a la FE, aunque no se alcanzaron diferencias estadísticamente significativas: olor, 0,04 (IC 95 %), de -0,49 a 0,56 (p = 0,092); sabor, 0,14 (IC 95 %), de -0,35 a 0,63 (p = 0,561); textura, 0,14, (IC 95 %), de -0,43 a 0,72 (p = 0,619). No se encontraron diferencias cuando se analizaron por orden de aleatorización, sexo, grado de desnutrición, mayor o menor grado de complejidad, mayor o menor tiempo de evolución de la diabetes, ni por ser más o menos mayores. Conclusiones: el suplemento nutricional específico para paciente con diabetes, formulado con aceite de oliva virgen extra, EPA y DHA, una mezcla específica en hidratos de carbono, fibra soluble e insoluble, presentó una adecuada aceptación sensorial del paciente desnutrido con diabetes mellitus tipo 2.

Glycaemic and insulinaemic impact of a diabetes-specific oral nutritional supplement with extra-virgin olive oil in patients with type 2 diabetes mellitus at nutritional risk: a randomized, double-blind, crossover, multicentre clinical trial (DIACARE).

Introduction: Introduction: there is controversy about the usefulness of specific enteral nutrition formulas in malnourished patients with diabetes. The effects on blood glucose and other aspects of metabolic control are not fully understood in the scientific literature. Objective: the aim of the study was to compare the glycaemic and insulinaemic response of patients with type 2 diabetes at risk of malnutrition after oral feed between a diabetes-specific formula with AOVE (DSF) and a standard one (STF). Methods: A randomized, double-blind, crossover, multicentre clinical trial was conducted in patients with type 2 diabetes at risk of malnutrition (SGA). The patients were randomized to receive either DSF or STF, a week apart. A glycaemia and insulinaemia curve was made at times 0 minutes, 30 min, 60 min, 90 min, 120 min, and 180 min after the patients drank 200 ml of the oral nutritional supplement (ONS). The principal variables were the area under the curve (AUC0-t) of glucose and insulin. Results: 29 patients (51 % women) were included, who were on average 68.84 (SD 11.37) years old. Regarding the degree of malnutrition, 86.2 % presented moderate malnutrition (B) and 13.8 % severe (C). When the patients received the DSF, they had a lower mean of glucose AUC0-t (-3,325.34 mg/min/dl [95 % CI: -4,3608.34 to -2,290.07]; p = 0.016) and also a lower mean of insulin AUC0-t (-451.14 uU/min/ml [95 % CI: -875,10 to -27.17]; p = 0.038). There were no differences in the degree of malnutrition. Conclusion: compared with STF, DSF with AOVE showed a better glycaemic and insulinaemic response in patients with type 2 diabetes at risk of malnutrition.

Introducción: Introducción: la utilidad de las fórmulas específicas de nutrición enteral en el paciente desnutrido con diabetes resulta controvertida. Sus efectos sobre la glucosa en sangre y otros aspectos del control metabólico no se conocen del todo en la literatura científica. Objetivo: el objetivo del estudio fue comparar la respuesta glucémica e insulinémica de los pacientes con diabetes tipo 2 (DM2) en riesgo de desnutrición tras la ingesta oral de una fórmula específica para diabetes (DSF) con aceite de oliva virgen extra (AOVE) y una estándar (STF). Métodos: ensayo clínico aleatorizado, doble ciego, cruzado y multicéntrico enpacientes con DM2 en riesgo de desnutrición (SGA). Los pacientes se asignaron aleatoriamente para recibir DSF o STF con una semana de diferencia. Se realizó una curva de glucemia e insulinemia en los siguientes tiempos: 0 minutos, 30 min, 60 min, 90 min, 120 min y 180 min tras la ingesta de 200 ml del suplemento nutricional oral (SNO). Las variables principales fueron el área bajo la curva (AUC0-t) de glucosa e insulina. Resultados: se incluyeron 29 pacientes (51 % mujeres), con una edad media de 68,84 años (DE 11,37). En cuanto al grado de desnutrición, el 86,2 % presentaba desnutrición moderada (B) y el 13,8 %, severa (C). Cuando los pacientes recibieron DSF tuvieron una media más baja de AUC0-t de glucosa (-3325,34 mg/min/dl [IC 95 %: de -4.3608,34 a -2.290,07]; p = 0,016) y también una media más baja de AUC0-t de insulina (-451,14 uU/min/ml [IC 95 %: de -875,10 a -27,17]; p = 0,038) respecto a cuando recibieron STF. No hubo diferencias por el grado de desnutrición. Conclusión: la fórmula con AOVE específica para diabetes mostró una mejor respuesta glucémica e insulinémica en pacientes con diabetes tipo 2 en riesgo de desnutrición respecto a una fórmula estándar.

Adopting a High-Polyphenolic Diet Is Associated with an Improved Glucose Profile: Prospective Analysis within the PREDIMED-Plus Trial.

Previous studies suggested that dietary polyphenols could reduce the incidence and complications of type-2 diabetes (T2D); although the evidence is still limited and inconsistent. This work analyzes whether changing to a diet with a higher polyphenolic content is associated with an improved glucose profile. At baseline, and at 1 year of follow-up visits, 5921 participants (mean age 65.0 ± 4.9, 48.2% women) who had overweight/obesity and metabolic syndrome filled out a validated 143-item semi-quantitative food frequency questionnaire (FFQ), from which polyphenol intakes were calculated. Energy-adjusted total polyphenols and subclasses were categorized in tertiles of changes. Linear mixed-effect models with random intercepts (the recruitment centers) were used to assess associations between changes in polyphenol subclasses intake and 1-year plasma glucose or glycosylated hemoglobin (HbA1c) levels. Increments in total polyphenol intake and some classes were inversely associated with better glucose levels and HbA1c after one year of follow-up. These associations were modified when the analyses were run considering diabetes status separately. To our knowledge, this is the first study to assess the relationship between changes in the intake of all polyphenolic groups and T2D-related parameters in a senior population with T2D or at high-risk of developing T2D.

Adherence to the Mediterranean Lifestyle and Desired Body Weight Loss in a Mediterranean Adult Population with Overweight: A PREDIMED-Plus Study.

BACKGROUND: Body weight dissatisfaction is a hindrance to following a healthy lifestyle and it has been associated with weight concerns. OBJECTIVES: The aim of this study was to assess the association between the adherence to the Mediterranean lifestyle (diet and exercise) and the desired body weight loss in an adult Mediterranean population with overweight. METHODS: Cross-sectional analysis in 6355 participants (3268 men; 3087 women) with metabolic syndrome and BMI (Body mass index) between 27.0 and 40.0 kg/m2 (55-75 years old) from the PREDIMED-Plus trial. Desired weight loss was the percentage of weight that participants wished to lose. It was categorized into four cut-offs of this percentage (Q1: <10%, n = 1495; Q2: 10-15%, n = 1804; Q3: <15-20%, n = 1470; Q4: ≥20%, n = 1589). Diet was assessed using a validated food frequency questionnaire and a 17-item Mediterranean diet questionnaire. Physical activity was assessed by the validated Minnesota-REGICOR and the validated Spanish version of the Nurses' Health Study questionnaire. RESULTS: Participants reporting higher percentages of desired weight loss (Q3 and Q4) were younger, had higher real and perceived BMI and were more likely to have abdominal obesity. Desired weight loss correlated inversely to physical activity (Q1: 2106 MET min/week; Q4: 1585 MET min/week. p < 0.001) and adherence to Mediterranean diet (Q1: 8.7; Q4: 8.3. p < 0.001). CONCLUSIONS: In older Mediterranean individuals with weight excess, desired weight loss was inversely associated with Mediterranean lifestyle adherence. Deeply rooted aspects of the MedDiet remained similar across groups. Longitudinal research is advised to be able to establish causality.

Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality are Associated with Metabolic Syndrome Severity: The PREDIMED-Plus Study.

Healthy lifestyle factors, such as physical activity (PA) and Mediterranean diet (MD), decrease the likelihood of developing metabolic syndrome (MetS). The aim of this study was to report main lifestyle components and related factors according to the MetS severity. Cross-sectional analysis was done of baseline lifestyle factors from 5739 participants with overweight/obesity and MetS features (aged 55-75 years) included in the PREDIMED-PLUS primary cardiovascular prevention randomized trial. Participants were categorized in tertiles according to a validated MetS severity score (MetSSS). Anthropometrics, visceral adiposity index, dietary nutrient intake, biochemical marker levels, as well as a Dietary Inflammatory Index and depression symptoms (Beck Depression Inventory-II) were measured. Diet quality was assessed using a 17-item energy-restricted MD questionnaire. Duration and intensity of PA was self-reported using the Minnesota-REGICOR Short Physical Activity Questionnaire. Sedentary behaviours were measured using the Spanish version of the Nurses' Health Study questionnaire. The 30 s chair stand test was also assessed. Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA). Highest MetSSS participants tended to a pro-inflammatory dietary pattern and tended to lower MD adherence. In addition, they showed lower carbohydrate and nut intake and higher intake of protein, saturated and trans fatty acids, cholesterol, iodine, sodium, red and processed meat products, other oils different from olive oil and spirit alcoholic drinks. The highest MetS severity score was associated with lower moderate and vigorous LTPA and higher sedentary time and depression risk, as they tended to a pro-inflammatory dietary pattern and lower MD adherence.