Low-carbohydrate Diet and Low-Density Lipoprotein - Cholesterol (LDL-c) Interindividual Variability

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bath

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

weight instability (>5% change in body mass within last 3 months)

smoker

diagnosis of hypercholesterolaemia or any other lipid-related disease

diagnosis of diabetes

Trial design

Design model

Crossover

Treatments tested in this trial

  • control diet

    Other intervention

    Diet will have macronutrients split with 50% carbohydrates, 15% protein and 35% fat. Also there will be a 0.66 ratio saturated:unsaturated fat

  • Low carbohydrate diet

    Other intervention

    Diet will have macronutrients split with 8% carbohydrates, 15% protein and 77% fat. Also there will be a 0.66 ratio saturated:unsaturated fat

Treatment groups

20 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Sequence 1Other 2 interventions
Group B: Sequence 2Other 2 interventions
Group C: Sequence 3Other 2 interventions
Group D: Sequence 4Other 2 interventions
Group E: Sequence 5Other 2 interventions
Group F: Sequence 6Other 2 interventions
Group G: Sequence 7Other 2 interventions
Group H: Sequence 8Other 2 interventions

Trial outcomes

Primary outcomes

1

Fasted plasma Low-density lipoprotein cholesterol (LDL-C) concentrations

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.

Time frame
Pre and post following each intervention/control diet for 24 hours

Secondary outcomes

1

Fasted glucose plasma glucose concentration

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

Time frame
Pre and post following each intervention/control diet for 24 hours

Other outcomes

Sponsors and contacts

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