Do ketone bodies help prevent diseases linked to overweight?
The Causal Role of Ketone Bodies in Obesity-Associated Disease Prevention - Combining Genetic Epidemiology With a Randomised Trial to Infer Causality
This study will try whether raising blood ketones with a ketogenic diet or a ketone supplement helps lower risk factors for heart disease, type 2 diabetes, and other obesity-related conditions in adults with overweight or moderate obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Bath Academic / other |
| Locations | 1 site (Bath, Bath) |
| Trial ID | NCT06668168 on ClinicalTrials.gov |
What this trial studies
This project combines genetic epidemiology with a randomized intervention to infer whether higher circulating ketone bodies causally reduce obesity-related disease risk. Adults with BMI 25–45 kg/m2 and elevated waist circumference, without diabetes, cardiovascular, liver or kidney disease, will be randomized to a ketogenic diet, ketone monoester supplementation, or control and followed for cardiometabolic markers. The genetic component uses inherited variants related to ketone metabolism to triangulate causal effects and strengthen inference beyond a single randomized comparison. The approach aims to separate effects of circulating ketones from harms linked to ketogenic diet composition and to identify whether ketone-raising interventions could be a practical preventive strategy.
Who should consider this trial
Good fit: Ideal participants are adults with overweight or moderate obesity (BMI 25–45 kg/m2) and elevated waist circumference who do not have type 2 diabetes, cardiovascular, liver or kidney disease, are not taking glucose- or lipid-lowering medications, and have no contraindication to a ketogenic diet.
Not a fit: People with established cardiovascular disease, type 2 diabetes, liver or renal failure, those on glucose- or lipid-lowering drugs, or with medical contraindications to ketogenic diets are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this work could identify a way to gain protective effects of ketosis—possibly via supplements—without long-term reliance on a high–saturated-fat ketogenic diet, reducing future risk of heart disease, diabetes, and other obesity-related conditions.
How similar studies have performed: Short-term trials and metabolic studies have shown ketogenic diets and ketone supplements can improve some cardiometabolic markers, but long-term disease prevention evidence is limited and combining randomized data with genetic methods is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index: 25-45 kg/m2 * Waist circumference \>93.9 (males) or \>79.9 (females) Exclusion Criteria: * Glucose or lipid lowering medication * Diagnosis of cardiovascular disease, renal failure, liver disease or type 2 diabetes * Contraindications to a ketogenic diet (e.g., pancreatitis, liver failure, disorders of fat metabolism, primary carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine translocase deficiency, porphyrias, or pyruvate kinase deficiency) * Unable to understand English language
Where this trial is running
Bath, Bath
- University of Bath — Bath, Bath, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Javier Gonzalez
- Email: j.t.gonzalez@bath.ac.uk
- Phone: +441225385518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.