Low-carbohydrate Diet and Low-Density Lipoprotein - Cholesterol (LDL-c) Interindividual Variability (REPETO)
25 de junio de 2026 actualizado por: Bruno Spellanzon, University of Bath
Exploring True Interindividual Heterogeneity of Cardiovascular Disease (CVD) Risk Factors in Response to Low-carbohydrate Diets Using a Replicate Crossover Randomised Controlled Trial
Ketogenic diets are very low-carbohydrate diets that increase hepatic production of ketone bodies, which have several effects as substrates and signals.
Ketogenic diets are used to manage some conditions (e.g., drug-resistant epilepsy), and their potential for managing many other conditions (e.g., cancer) is being actively explored.
Indeed, the British Dietetic Association acknowledge the potential for ketogenic diets to improve glycaemic control to a greater extent than some other diets in people with type 2 diabetes.
A lower fasting glucose is also relevant to future mortality in people without diabetes.
Ketogenic diets are popular in the general population, with up to 15% of the UK following a low-carbohydrate diet.
There is, therefore, great interest in ketogenic diets amongst people with and without health conditions.
However, although the diet shows promising results in improving blood sugar levels, it has also shown to increase low-density lipoprotein-cholesterol (LDL-c) in some individuals, which has been linked to increased cardiovascular health risks.
The aim of this project is to find the potential for personalised use of (or guidance to avoid) ketogenic diets for cardiovascular disease risk.
To do that the investigators will ask participants to replicate 24 hours of a ketogenic diet and a control diet thrice each.
This will allow the investigators to find variability between responses and have a better idea of individuals who could benefit (or not) from following the ketogenic diet.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will be a controlled feeding replicate randomised controled trial with 3 cycles, each involving the pair of diets [low carbohydrate (K) and control (C) diets]. There will be 6 x 1-day periods (3 days low carbohydrate and 3 days control). Twenty individuals (body mass index: 18.5-35 kg/m2) will be recruited and randomised into one of the 8 possible sequences:
- KC KC KC
- KC KC CK
- KC CK KC
- KC CK CK
- CK CK CK
- CK CK KC
- CK KC CK
- CK KC KC A week before the interventions start, participants will visit the laboratory so that the investigators can perform indirect calorimetry and collect a blood sample for genotyping. During the week before the interventions, participants will wear activity monitors to determine habitual physical activity. Before each visit, participants will be asked to come to the lab in a rested and overnight fasted state. During the first trial visit, participants will have a dual-energy X-ray absorptiometry (DEXA) body scan to determine body composition. During all 12 study visits the investigators will perform a venepuncture in an antecubital vein and will collect 20 mL of blood.
Additionally, the investigators will also collect urine samples. After odd visits (1st, 3rd, 5th, 7th, 9th and 11th), participants will be supplied with their respective meals for the day (low carbohydrate or control) and will be asked to not eat anything else during the day.
Finally there will be a wash-out period of 6 days between laboratory visits. To keep consistency between trial days, participants will be asked to replicate physical activity levels performed during the 24 hours before the first trial, and during diet day (before second visit), so that these can be replicated for the following visits.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bruno Spellanzon, PhD candidate
- Número de teléfono: 447769407954
- Correo electrónico: bs954@bath.ac.uk
Ubicaciones de estudio
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Bath and North East Somerset
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Bath, Bath and North East Somerset, Reino Unido, BA2 7AY
- Reclutamiento
- University of Bath
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Investigador principal:
- Javier Gonzalez, PhD
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Contacto:
- Bruno Spellanzon, PhD candidate
- Número de teléfono: 447769407954
- Correo electrónico: bs954@bath.ac.uk
-
Contacto:
- Javier Gonzalez, PhD
- Correo electrónico: jg833@bath.ac.uk
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age: >18 years
- Body mass index: 18.5-35 kg·m-2
- Low-Density Lipoprotein-cholesterol <4.9 mmol/L
- Non-fasting triglycerides <2.3 mmol/L
Exclusion Criteria:
- weight instability (>5% change in body mass within last 3 months)
- smoker
- diagnosis of hypercholesterolaemia or any other lipid-related disease
- diagnosis of diabetes
- diagnosis of atherosclerotic cardiovascular disease
- elevated fasting glucose (>5.4 mmol/L)
- dietary intolerances or allergies or to other study procedures
- diagnosis of gastrointestinal disorders
- any other condition/medication that could introduce bias to the study
- already following a ketogenic diet
- not willing to follow a ketogenic diet
- unable to understand English language
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Sequence 1
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 2
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 3
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 4
Participants will follow a 1) low-carbohydrate diet, wash-out, 2) control diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 5
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 6
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) control diet, wash-out, 4) low-carbohydrate diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 7
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) control diet, wash-out, 6) low-carbohydrate diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
|
Otro: Sequence 8
Participants will follow a 1) control diet, wash-out, 2) low-carbohydrate diet, wash-out, 3) low-carbohydrate diet, wash-out, 4) control diet, wash-out, 5) low-carbohydrate diet, wash-out, 6) control diet
|
Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat.
Also there will be a 0.66 ratio saturated:unsaturated fat
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fasted plasma Low-density lipoprotein cholesterol (LDL-C) concentrations
Periodo de tiempo: Pre and post following each intervention/control diet for 24 hours
|
Variable will be used to establish whether there is true inter-individual heterogeneity in response to 24 hours of a low-carbohydrate diet. Measured in mmol/L. |
Pre and post following each intervention/control diet for 24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fasted glucose plasma glucose concentration
Periodo de tiempo: Pre and post following each intervention/control diet for 24 hours
|
Variable measured to establish whether there is true inter-individual heterogeneity in response to 24 hours of a low-carbohydrate diet. Measured in mmol/L |
Pre and post following each intervention/control diet for 24 hours
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Javier Gonzalez, PhD, University of Bath
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de febrero de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
30 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8791-12081
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .