Nutritional and Metabolic DiseasesBoLDNCT05973539
Blood Lipid Responses to Diet Macronutrients
A study testing Diet in people with Nutritional and Metabolic Diseases, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Feb 2023to Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Leane Hodson contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford
Oxford, OX3 7LE
Leanne Hodson, PhD, 01865 857224, leanne.hodson@ocdem.ox.ac.uk
- Recruiting
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, OX3 7LE
Leanne Hodson, 01865 857224, leanne.hodson@ocdem.ox.ac.uk
Leanne Hodson, PhD
About this study
Official title: Investigating Blood Lipid Responses to Dietary Macronutrient Content
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.
Read the detailed description
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.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- Diet
- Medical subject headings
- Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
| Study group | Role | What they receive |
|---|---|---|
| High carbohydrate, low fat diet | Experimental | 65% of energy is derived from carbohydrates, 20% from fat, and 15% from protein. Receives: Other: Diet |
| High fat, low carbohydrate diet | Experimental | 65% of energy is derived from fat, 20% from carbohydrates, and 15% from protein. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- and post-diet [21-28 days]
Secondary outcomes (5)
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
Measured: Pre- and post-diet [21-28 days]
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
Measured: Pre- and post-diet [21-28 days]
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.
Measured: Pre- and post-diet [21-28 days]
Change in hepatic fatty acid synthesis
Measured by incorporation of [2H2] palmitate from 2H2O into VLDL-triglyceride
Measured: Pre- and post-diet [21-28 days]
Influence of genotype on the change in plasma lipid content [mmol/L]
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.
Measured: Pre- and post-diet [21-28 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start15 Feb 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leane Hodson, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973539
- Sponsor's protocol ID
- 316098
- Acronym
- BoLD
- Status last verified
- May 2026
- First submitted
- 9 Jan 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD with other researchers