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Short-term Fat Overfeeding on the Effects of Liver Metabolism

The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05962190
Acronym
FOS
Enrollment
26
Registered
2023-07-27
Start date
2023-02-15
Completion date
2028-02-29
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity, Cardiac Function, Lipid Disorder, Liver Fat

Brief summary

Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk. To explore this, we are undertaking a human in vivo parallel-design study, comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on postprandial metabolism, liver fat, cardiac fat and cardiac function.

Detailed description

The investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism. Purpose and design: The investigators are asking the research question: How does the amount and type of fat consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver fat metabolism when someone is not gaining or losing body weight? To address this research question investigators want to undertake detail physiological studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to assess how their metabolic response to a experimental test meal, before and then 28 days after consumption of a eucaloric, high fat intervention diet that will be either enriched in saturated or unsaturated fat.

Interventions

BEHAVIORALDiet

High fat (\ 60% of total energy intake) diet enriched with either SFA or UFA

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* The participant is willing and able to give informed consent for participation in the study. * Male or Female, aged ≥18 or ≤65 years. * Body Mass Index ≥19 ≤35 kg/m2 * No medical condition or relevant drug therapy that is known to affect liver or adipose tissue metabolism. * Weight stable for the previous 3 months

Exclusion criteria

* The participant is unwilling or unable to give informed consent for participation in the study. - Aged ≤18 or ≥65 years * Body Mass Index ≤19 or ≥35kg/m2 * Blood haemoglobin \<135mg/dL for men and \<120mg/dL for women * Donated (or lost) ≥250 ml of blood in the previous two months. * On a weight loss diet or have decreased their body weight by \>5% in the previous 3 months. * 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) * Haemorrhagic disorders * Anticoagulant treatment * History of albumin allergy * Pregnant or nursing mothers * Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months History of severe claustrophobia * Presence of metallic implants, pacemakers, or are unwilling to remove any piercings * History of an eating disorder or any other psychological condition that may affect the participant's ability to adhere to study intervention/experimental diets.

Design outcomes

Primary

MeasureTime frameDescription
Liver fatPre- and after approx 28 days of consuming interventional dietChanges in intrahepatic triglyceride, as measured by MRI

Secondary

MeasureTime frameDescription
Postprandial plasma biochemistryPre- and after approx 28 days of consuming interventional dietChanges in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal

Countries

United Kingdom

Contacts

Primary ContactLeanne Hodson
leanne.hodson@ocdem.ox.ac.uk01865 857224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026