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Blood Lipid Responses to Diet Macronutrients

Sponsor: University of Oxford

NCT ID: NCT05973539

View on ClinicalTrials.gov ↗

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.

Nutritional and Metabolic Diseases

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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
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 Is This Study? (2 UK sites)

Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Leanne Hodson, PhDPrincipal Investigator

How to Get in Touch

David J Dearlove

Sponsor contact

CONTACT

07739460623 david.dearlove@ocdem.ox.ac.uk

Leane Hodson

Sponsor contact

CONTACT

leanne.hodson@ocdem.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-05