Effects of diet on blood lipids and metabolism
Investigating Blood Lipid Responses to Dietary Macronutrient Content
This study is testing whether a low carbohydrate, high-fat diet or a high carbohydrate, low-fat diet can better improve blood fat levels and liver health in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 2 sites (Oxford and 1 other locations) |
| Trial ID | NCT05973539 on ClinicalTrials.gov |
What this trial studies
This study investigates how different macronutrient compositions in diets, specifically high carbohydrate versus high fat, affect blood lipid responses and liver metabolism in adults without metabolic diseases. Participants will be randomly assigned to consume either a low carbohydrate, high-fat diet or a high carbohydrate, low-fat diet for up to 28 days while maintaining stable body weight. The study also aims to explore the interaction between dietary macronutrient content and individual genetic factors on metabolic responses. By analyzing plasma triglyceride concentrations and liver fat content, the research seeks to clarify optimal dietary approaches for reducing the risk of cardiometabolic diseases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a BMI between 19 and 35 who are free from metabolic diseases.
Not a fit: Patients with metabolic conditions or those currently on weight loss diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide personalized dietary recommendations to lower the risk of cardiometabolic diseases.
How similar studies have performed: Other studies have explored dietary impacts on metabolic health, but this specific approach examining genetic interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged ≥18 to ≤65 years * Body mass index (BMI) ≥19 to ≤35 kg/m2 * No medical condition or relevant drug therapy that is known to affect the liver, adipose tissue, or cardiac metabolism. * Weight stable for the previous 3 months Exclusion Criteria: * Aged \<18 or \>65 years * BMI \<19 or \>35 kg/m2 * A blood haemoglobin \<135 mg/dL for men and \<120 mg/dL for women * Donated (or lost) ≥250 mL of blood in the previous two months * On a weight loss diet or decreased their body weight by \>5% in the previous 3 months * Currently adhering to or have consumed in the previous 3 months a diet with a notably altered macro-nutrient content (e.g. high-fat - low-carbohydrate diet) * Have increased their body weight by \>5% in the previous 3 months * Any metabolic condition or relevant drug therapy * Current smoker * History of alcoholism or a greater than recommended alcohol intake (\>30 g of alcohol daily for men and \>20 g of alcohol daily for women) * History of albumin allergy. * Pregnant or nursing mothers * History of severe claustrophobia
Where this trial is running
Oxford and 1 other locations
- Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford — Oxford, United Kingdom (Recruiting)
- Oxford Centre for Diabetes, Endocrinology and Metabolism — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Leane Hodson — University of Oxford
- Study coordinator: David J Dearlove
- Email: david.dearlove@ocdem.ox.ac.uk
- Phone: 07739460623
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.