Diet
OtherEucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
NCT Number: NCT05973539
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
Time frame: Pre- and post-diet [21-28 days]
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]
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]
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]
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]
Measured by incorporation of [2H2] palmitate from 2H2O into VLDL-triglyceride
Time frame: Pre- and post-diet [21-28 days]
Change in plasma lipid concentrations in the fasting state and in response to consumption of macronutrient meal will be measured by basic clinical chemistry before and at the end of the dietary intervention.
Contact information is provided by the study sponsor or research team.
University of Oxford
Other
Investigating Blood Lipid Responses to Dietary Macronutrient Content
Acronym: BoLD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07575932
Body Weight, Nutrition Disorders
Chandler, Arizona, United States
View Trial DetailsNCT07699380
Autoimmune Diseases, Combination Therapy
Seattle, Washington, United States
View Trial DetailsNCT06482944
Diabetes Mellitus, Diet, Healthy
Nashville, Tennessee, United States
View Trial DetailsNCT07036692
Body Weight, Nutrition Disorders
Bern, Switzerland
View Trial Details