Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Low-carbohydrate Diet and LDL Cholesterol: How Diet Affects People Differently

Official title: Exploring True Interindividual Heterogeneity of Cardiovascular Disease (CVD) Risk Factors in Response to Low-carbohydrate Diets Using a Replicate Crossover Randomised Controlled Trial

Run by University of Bath · NCT07675603 · Data updated 2026-11-12

A controlled feeding study tests whether a very low-carbohydrate ketogenic diet changes LDL cholesterol differently among healthy adults using a rotating sequence of keto and control meals.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity of Bath
Academic / other
Locations1 site (Bath, Bath and North East Somerset)
StatusRecruiting
StartedFebruary 5, 2026
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedJune 30, 2026
Trial IDNCT07675603 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with BMI 18.5–35 kg/m2 and LDL-C below 4.9 mmol/L who can follow a ketogenic diet and attend repeated lab visits.

Probably not a fit

Individuals who cannot adhere to a ketogenic diet or have conditions affecting lipid metabolism may receive limited or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a randomized crossover design where 20 healthy adults receive both a low-carbohydrate ketogenic diet and a control diet in alternating 1-day blocks across 3 cycles. Researchers will measure metabolism, body composition, blood and urine markers, and activity to see how LDL-C responds to each diet and whether individual factors influence the response. Participants stay in a controlled setting with standardized meals, fasting states, and washouts between visits. Indirect calorimetry, blood draws, DEXA scans, and genotyping are used to characterize responses. The aim is to understand interindividual variability in LDL-C changes during ketogenic feeding.

Why it matters

Potential benefit: If successful, the study could clarify who might experience LDL-C changes on ketogenic diets, informing personalized dietary guidance.

How similar studies have gone: Previous work in dietary interventions suggests variability in lipid responses; this study builds on a controlled design to characterize that variability.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Bath
    Bath, Bath and North East Somerset, United Kingdom
    Recruiting

Study contacts

  • Principal investigator: Javier Gonzalez, PhD — University of Bath
  • Study coordinator: Bruno Spellanzon, PhD candidate
  • Email: bs954@bath.ac.uk
  • Phone: 447769407954

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.