Low-carbohydrate Diet and Low-Density Lipoprotein - Cholesterol (LDL-c) Interindividual Variability (REPETO)
25 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Bruno Spellanzon, PhD candidate
- Número de telefone: 447769407954
- E-mail: bs954@bath.ac.uk
Locais de estudo
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Bath and North East Somerset
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Bath, Bath and North East Somerset, Reino Unido, BA2 7AY
- Recrutamento
- University of Bath
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Investigador principal:
- Javier Gonzalez, PhD
-
Contato:
- Bruno Spellanzon, PhD candidate
- Número de telefone: 447769407954
- E-mail: bs954@bath.ac.uk
-
Contato:
- Javier Gonzalez, PhD
- E-mail: jg833@bath.ac.uk
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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
|
|
Outro: 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
|
|
Outro: 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
|
|
Outro: 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
|
|
Outro: 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
|
|
Outro: 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
|
|
Outro: 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
|
|
Outro: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fasted plasma Low-density lipoprotein cholesterol (LDL-C) concentrations
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fasted glucose plasma glucose concentration
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Javier Gonzalez, PhD, University of Bath
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
5 de fevereiro de 2026
Conclusão Primária (Estimado)
1 de março de 2027
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
5 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de junho de 2026
Primeira postagem (Real)
30 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 8791-12081
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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