- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02679989
The Impact Of An Intermittent Energy Restricted Diet On Insulin Sensitivity In Men and Women With Central Obesity (Met-IER)
A Randomised Controlled Trial Assessing The Impact Of An Intermittent Energy Restricted Diet On Weight Loss, Insulin Sensitivity and Heart Rate Variability In Men and Women With Central Obesity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prediabetes rates in England have showed a marked increase, more than tripling between 2003 and 2011. It is characterised by an impaired fasting glucose or impaired glucose tolerance that increases the risk of progression to type 2 diabetes (T2D). It has been estimated that approximately 90% of T2D is attributed to excess weight. Central obesity is a primary driver of increased cardiometabolic risk due to its lipotoxicity effects, promoting a proinflammatory state that facilitates insulin resistance and beta cell dysfunction. A high waist circumference measurement, indicative of central obesity, is associated with increased risk of cardiovascular diseases and T2D, and is a stronger predictor of T2D than BMI. BMI has limitations as an indicator of adiposity since it doesn't distinguish lean from fat mass, and does not indicate body fat distribution. Conventionally, continuous energy restriction (CER) diets have been used for weight loss, which consist of a constant daily energy deficit relative to total energy expenditure. The impact on weight loss and health of an intermittent energy restriction (IER) approach has only rarely been investigated (although the "5:2 diet" has been popularised in lifestyle books aimed at the general public). An IER diet consists of a predefined period of time severely restricting energy intake, alternated with a period of greater energy intake. This approach was shown to confer metabolic benefits in overweight and obese women at risk of breast cancer with baseline BMI of 2445 (Harvie et al., 2013; Harvie et al., 2011).
Rationale: An IER diet using meal replacements (VLCD foodpacks used as total dietary replacements for 2 consecutive days each week, and a food-based energy-restricted diet for the other 5 days of the week) may modify cardio-metabolic disease risk factors compared to an energy-matched CER diet.
Research question: In centrally obese subjects, assessed by a high waist circumference measurement, does adherence to an IER diet have enhanced cardio-metabolic benefits compared to a CER diet? Hypothesis: Increases in insulin sensitivity following a 4 week dietary intervention with an IER weight loss programme will be greater compared to a standard CER programme.
Objectives:
- A randomised controlled parallel design trial will determine the impact of a short-term IER diet compared to a CER diet on primary outcome variables (insulin sensitivity) in healthy subjects with a high waist circumference.
- To assess the impact of an IER diet on secondary outcome variables, including body composition, heart rate variability (HRV, a measure of cardiac autonomic function, including parasympathetic and sympathetic activity), blood pressure, vascular function, other markers of insulin resistance, inflammation/adipokines, plasma lipid profile, plasma norepinephrine, ketosis, the gut microbiome and cognitive function in healthy subjects with a high waist circumference.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
England
-
London, England, Reino Unido, SE1 9NH
- Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Buiding, 150 Stamford St.
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged >35-75 years
- Waist circumference above cut-off for high risk of cardio-metabolic disease of >102 cm in men with a Europid, Black African and Caribbean, and other ethnic background and >88 cm in women with a Europid, Black African and Caribbean, and other ethnic background (WHO, 2008), and ≥90 cm in men and ≥80 cm in women with an Asian background (South Asian and East Asian) (Misra et al., 2009).
REFERENCES Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D, et al. (2009). Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. The Journal of the Association of Physicians of India 57: 163170.
WHO (2008). Waist circumference and waist-hip ratio: report of a WHO expert consultation. Geneva, 8-11 December 2008.
Exclusion Criteria:
- Kidney or cardiovascular disease, cancer, diabetes, gastrointestinal or chronic liver disease;
- previous bariatric surgery or other major surgery (e.g. organ transplantation);
- unable to provide written informed consent;
- have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, attention deficit disorder, post-traumatic stress disorder, obsessive compulsive disorder) or uncontrolled depression;
- participated in a weight management drug trial in the previous 3 months;
- have binge eating behaviour;
- have uncontrolled epilepsy;
- alcohol or substance abuse;
- currently pregnant, lactating, or planning pregnancy within the study period;
- are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc);
- lactose intolerant.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intermittent Energy Restriction
Weight loss intervention: Intermittent Energy Restriction
|
Dietary advice to follow 5:2 diet supported by physical activity advice and motivational group support sessions
|
Comparador activo: Continuous Energy Restriction
Weight loss intervention: Continuous Energy Restriction
|
Dietary advice to follow daily energy restricted diet supported by physical activity advice and motivational group support sessions
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Revised QUICKI (RQUICKI)
Periodo de tiempo: Baseline
|
Marker of insulin sensitivity
|
Baseline
|
RQUICKI
Periodo de tiempo: day 29
|
Marker of insulin sensitivity
|
day 29
|
RQUICKI
Periodo de tiempo: day 31
|
Marker of insulin sensitivity
|
day 31
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Peso corporal
Periodo de tiempo: Base
|
Base
|
|
Circunferencia de la cintura
Periodo de tiempo: Base
|
Base
|
|
Circunferencia de la cadera
Periodo de tiempo: Base
|
Base
|
|
Concentración de glucosa en plasma
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Concentración de adiponectina en plasma
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Concentración de leptina en plasma
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Concentración de colesterol total en plasma
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Concentración de colesterol de lipoproteínas de baja densidad (LDL) en plasma
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Concentración plasmática de colesterol de lipoproteínas de alta densidad (HDL)
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Concentración de triglicéridos en plasma
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Relación colesterol total plasmático:colesterol HDL
Periodo de tiempo: Base
|
Ayuno
|
Base
|
Índice de masa corporal (IMC)
Periodo de tiempo: Base
|
Base
|
|
Plasma glucose concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma glucose concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma insulin concentration
Periodo de tiempo: Baseline
|
Fasting
|
Baseline
|
Plasma insulin concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma insulin concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma non-esterified fatty acid concentration
Periodo de tiempo: Baseline
|
Fasting
|
Baseline
|
Plasma non-esterified fatty acid concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma non-esterified fatty acid concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma total cholesterol concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma total cholesterol concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma LDL cholesterol concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma LDL cholesterol concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma HDL cholesterol concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma HDL cholesterol concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma triglyceride concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma triglyceride concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma total cholesterol:HDL cholesterol ratio
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma total cholesterol:HDL cholesterol ratio
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Periodo de tiempo: Baseline
|
Fasting (calculated from insulin and glucose)
|
Baseline
|
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Periodo de tiempo: day 29
|
Fasting (calculated from insulin and glucose)
|
day 29
|
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Periodo de tiempo: day 31
|
Fasting (calculated from insulin and glucose)
|
day 31
|
Plasma adiponectin concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma adiponectin concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma leptin concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma leptin concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma interleukin-6 concentration
Periodo de tiempo: Baseline
|
Fasting
|
Baseline
|
Plasma interleukin-6 concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma interleukin-6 concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma beta-hydroxybutyrate concentration
Periodo de tiempo: Baseline
|
Fasting
|
Baseline
|
Plasma beta-hydroxybutyrate concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma beta-hydroxybutyrate concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma norepinephrine concentration
Periodo de tiempo: Baseline
|
Fasting
|
Baseline
|
Plasma norepinephrine concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma norepinephrine concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Plasma soluble alpha-klotho concentration
Periodo de tiempo: Baseline
|
Fasting
|
Baseline
|
Plasma soluble alpha-klotho concentration
Periodo de tiempo: day 29
|
Fasting
|
day 29
|
Plasma soluble alpha-klotho concentration
Periodo de tiempo: day 31
|
Fasting
|
day 31
|
Body weight
Periodo de tiempo: day 29
|
day 29
|
|
Body weight
Periodo de tiempo: day 31
|
day 31
|
|
BMI
Periodo de tiempo: day 29
|
day 29
|
|
BMI
Periodo de tiempo: day 31
|
day 31
|
|
Waist circumference
Periodo de tiempo: day 29
|
day 29
|
|
Waist circumference
Periodo de tiempo: day 31
|
day 31
|
|
Hip circumference
Periodo de tiempo: day 29
|
day 29
|
|
Hip circumference
Periodo de tiempo: day 31
|
day 31
|
|
Percentage body fat
Periodo de tiempo: Baseline
|
Baseline
|
|
Percentage body fat
Periodo de tiempo: day 29
|
day 29
|
|
Percentage body fat
Periodo de tiempo: day 31
|
day 31
|
|
Percentage lean body mass
Periodo de tiempo: Baseline
|
Baseline
|
|
Percentage lean body mass
Periodo de tiempo: day 29
|
day 29
|
|
Percentage lean body mass
Periodo de tiempo: day 31
|
day 31
|
|
Heart rate variability (resting)
Periodo de tiempo: Baseline
|
supine
|
Baseline
|
Heart rate variability (resting)
Periodo de tiempo: day 29
|
supine
|
day 29
|
Heart rate variability (resting)
Periodo de tiempo: day 31
|
supine
|
day 31
|
Heart rate variability (ambulatory)
Periodo de tiempo: 24 h recording at baseline
|
24 h recording at baseline
|
|
Heart rate variability (ambulatory)
Periodo de tiempo: 24 h recording on day 29
|
24 h recording on day 29
|
|
Heart rate variability (ambulatory)
Periodo de tiempo: 24 h recording on day 31
|
24 h recording on day 31
|
|
Heart rate variability (sleep-time)
Periodo de tiempo: Baseline
|
Baseline
|
|
Heart rate variability (sleep-time)
Periodo de tiempo: day 29
|
day 29
|
|
Heart rate variability (sleep-time)
Periodo de tiempo: day 31
|
day 31
|
|
Heart rate variability (during mental stress)
Periodo de tiempo: Baseline
|
Baseline
|
|
Heart rate variability (during mental stress)
Periodo de tiempo: day 29
|
day 29
|
|
Heart rate variability (during mental stress)
Periodo de tiempo: day 31
|
day 31
|
|
Ambulatory blood pressure 24 h
Periodo de tiempo: 24 h analysis at baseline
|
24 h analysis at baseline
|
|
Ambulatory blood pressure daytime
Periodo de tiempo: Daytime analysis at baseline
|
Daytime analysis at baseline
|
|
Ambulatory blood pressure night-time
Periodo de tiempo: Night-time analysis at baseline
|
Night-time analysis at baseline
|
|
Ambulatory blood pressure 24 h
Periodo de tiempo: 24 h analysis on day 29
|
24 h analysis on day 29
|
|
Ambulatory blood pressure daytime
Periodo de tiempo: daytime analysis on day 29
|
daytime analysis on day 29
|
|
Ambulatory blood pressure night-time
Periodo de tiempo: night-time analysis on day 29
|
night-time analysis on day 29
|
|
Ambulatory blood pressure 24 h
Periodo de tiempo: 24 h analysis on day 31
|
24 h
|
24 h analysis on day 31
|
Ambulatory blood pressure daytime
Periodo de tiempo: Daytime analysis on day 31
|
day time
|
Daytime analysis on day 31
|
Ambulatory blood pressure night-time
Periodo de tiempo: Night-time analysis on day 31
|
night-time
|
Night-time analysis on day 31
|
Digital volume pulse - stiffness index (SI)
Periodo de tiempo: Baseline
|
Stiffness index
|
Baseline
|
Digital volume pulse - SI
Periodo de tiempo: day 29
|
Stiffness index
|
day 29
|
Digital volume pulse - SI
Periodo de tiempo: day 31
|
Stiffness index
|
day 31
|
Digital volume pulse - reflection index (RI)
Periodo de tiempo: Baseline
|
reflection index
|
Baseline
|
Digital volume pulse - RI
Periodo de tiempo: day 29
|
reflection index
|
day 29
|
Digital volume pulse - RI
Periodo de tiempo: day 31
|
reflection index
|
day 31
|
Mnemonic Similarity Test
Periodo de tiempo: Baseline
|
Baseline
|
|
Mnemonic Similarity Test
Periodo de tiempo: day 29
|
day 29
|
|
Mnemonic Similarity Test
Periodo de tiempo: day 31
|
day 31
|
|
Power of food scale
Periodo de tiempo: Baseline
|
questionnaire
|
Baseline
|
Power of food scale
Periodo de tiempo: day 29
|
questionnaire
|
day 29
|
Power of food scale
Periodo de tiempo: day 31
|
questionnaire
|
day 31
|
COPE (not an acronym)
Periodo de tiempo: Baseline
|
questionnaire
|
Baseline
|
COPE
Periodo de tiempo: day 29
|
questionnaire
|
day 29
|
COPE
Periodo de tiempo: day 31
|
questionnaire
|
day 31
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
Adverse events
Periodo de tiempo: Baseline until endpoint: day 31 (+/-1 day)
|
Baseline until endpoint: day 31 (+/-1 day)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.
- Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
- Kim C, Pinto AM, Bordoli C, Buckner LP, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL, Thuret S. Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial. Nutrients. 2020 Feb 28;12(3):638. doi: 10.3390/nu12030638.
- Pinto AM, Bordoli C, Buckner LP, Kim C, Kaplan PC, Del Arenal IM, Jeffcock EJ, Hall WL. Intermittent energy restriction is comparable to continuous energy restriction for cardiometabolic health in adults with central obesity: A randomized controlled trial; the Met-IER study. Clin Nutr. 2020 Jun;39(6):1753-1763. doi: 10.1016/j.clnu.2019.07.014. Epub 2019 Jul 30.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Met-IER2016
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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