At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Diet (other)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- Diet — other: Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 60
- Started
- 2023-02-15
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for nutritional and metabolic diseases
- • NA - 60 participants
- • The macronutrient composition of a diet (proportions of carbohydrates, fats and proteins) strongly influences the way the body stores and utilises substrates (e
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with nutritional and metabolic diseases
Where?
- • Oxford - Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford
- • Oxford - Oxford Centre for Diabetes, Endocrinology and Metabolism
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The macronutrient composition of a diet (proportions of carbohydrates, fats and proteins) strongly influences the way the body stores and utilises substrates (e.g., fats and sugars), which in turn influences the risk of developing cardiometabolic diseases (e.g., coronary artery disease or insulin resistance). The optimal dietary composition to lower the risk of cardiometabolic disease is unknown. In a randomized, parallel design, this study will investigate how the overconsumption of carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from metabolic disease. By genotyping participants, the interaction between macronutrient content and an individual's genes on blood lipid responses and liver metabolism will be examined.
More detail
Dietary and lifestyle interventions are central to lowering the risk and preventing the development of metabolic disease, including non-alcoholic fatty liver disease, type 2 diabetes, and cardiovascular disease. There is, however, no one fits all dietary approach, and in the context of diets where an individual is not gaining or losing weight (known as eucaloric), the optimal macronutrient composition associated with a reduced risk of metabolic disease and dyslipidemia is highly debated. For instance, eating less of one macronutrient implies eating more of another; a reduction in the intake of dietary carbohydrates is met by an increase in dietary fats. How this affects one's metabolic health in the setting when someone is not gaining or losing body weight is unclear. Therefore, this study aims to provide an understanding of the effect that the quantity of specific dietary macronutrients (e.g., carbohydrates, fats) have on plasma triglyceride concentrations in both the fasting and postprandial state, liver fat content and metabolism, and cardiac fat content and function. An individual's genotype affects the metabolic response to a shift in dietary macronutrient content and this will be examined in this study. Sixty volunteers free from metabolic disease will be recruited into a randomized, parallel-armed dietary intervention study. Participants will consume either a low carbohydrate, high-fat diet or a high carbohydrate, low-fat diet for up to 28 days. Diets will be eucaloric (i.e., designed to meet the individual participant's energy requirements). Comprehensive in vivo metabolic and physiological testing will be performed before and after the experimental diet to document the effects of the overconsumption of specific macronutrients (i.e., fats or carbohydrates) on liver and lipid metabolism.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓Participant is willing and able to give agreement to take part 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 heart metabolism.
- ✓Weight stable for the previous 3 months
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford
Oxford OX3 7LE, United Kingdom
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford OX3 7LE, United Kingdom
How to Get in Touch
David J Dearlove
Sponsor contactCONTACT
Leane Hodson
Sponsor contactCONTACT
