Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-02-15
2028-01-31
Brief Summary
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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, we will also examine the interaction between macronutrient content and an individual's genes on blood lipid responses and liver metabolism.
Detailed Description
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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. We will also examine if an individual's genotype affects the metabolic response to a shift in dietary macronutrient content.
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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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High carbohydrate, low fat diet
65% of energy is derived from carbohydrates, 20% from fat, and 15% from protein.
Diet
Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
High fat, low carbohydrate diet
65% of energy is derived from fat, 20% from carbohydrates, and 15% from protein.
Diet
Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
Interventions
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Diet
Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Leane Hodson
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford
Oxford, , United Kingdom
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Leanne Hodson, PhD
Role: primary
Leanne Hodson
Role: primary
Other Identifiers
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316098
Identifier Type: -
Identifier Source: org_study_id