Short-term Fat Overfeeding on the Effects of Liver Metabolism (FOS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Fat; Adiposity; Lipid Disorder; Cardiac Function
• Intervention / Treatment: Behavioral: Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leanne Hodson; Phone Number: 01865 857224; Email: leanne.hodson@ocdem.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LE
    • Recruiting
    • Oxford Centre for Diabetes, Endocrinology and Metabolism
    • Principal Investigator: Leanne Hodson, PhD
    • Contact: Leanne Hodson; Phone Number: 01865 857224; Email: leanne.hodson@ocdem.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High fat, high SFA; ~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA	Behavioral: Diet; High fat (~60% of total energy intake) diet enriched with either SFA or UFA
Experimental: High fat, high UFA; ~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA	Behavioral: Diet; High fat (~60% of total energy intake) diet enriched with either SFA or UFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver fat	Changes in intrahepatic triglyceride, as measured by MRI	Pre- and after approx 28 days of consuming interventional diet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial plasma biochemistry	Changes in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal	Pre- and after approx 28 days of consuming interventional diet

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Leanne Hodson, PhD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: 211172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No