An interventional study of control diet and Low carbohydrate diet in Healthy, sponsored by University of Bath. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University of Bath · Not applicable, Interventional, and Basic science
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.
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:
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.
University of Bath is the lead sponsor of 94 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: Low carbohydrate diet
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
Other: control diet · Other: 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
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Started Feb 2026 (actual). Primary completion is estimated for Mar 2027, 13 months after the start.
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