Blood Lipid Responses to Diet Macronutrients
ConditionNutritional and Metabolic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Oxford
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Diet
Other interventionEucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: High carbohydrate, low fat dietExperimental treatment 1 intervention
Group B: High fat, low carbohydrate dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in plasma triglyceride concentrations [mmol/L]
Change in plasma triglyceride concentrations in response to consumption of macronutrient meal will be measured by basic clinical chemistry before and at the end of the dietary intervention.
Time frame
Pre- and post-diet [21-28 days]Secondary outcomes
1
Change in liver fat content [%]
Liver fat content (intra-hepatic triglyceride) will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy
Time frame
Pre- and post-diet [21-28 days]2
Change in cardiac fat content [%]
Cardiac fat content will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy
Time frame
Pre- and post-diet [21-28 days]3
Change in the contribution of dietary and adipose tissue derived fatty acids to very low density lipoprotein-triglyceride (VLDL-TG) palmitate
Through measuring the incorporation of \[13C\]palmitate and \[2H2\]palmitate in isolated plasma VLDL during a mixed-macronutrient feeding test.
Time frame
Pre- and post-diet [21-28 days]4
Change in hepatic fatty acid synthesis
Measured by incorporation of \[2H2\] palmitate from 2H2O into VLDL-triglyceride
Time frame
Pre- and post-diet [21-28 days]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov