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

Primary Purpose

Liver Fat, Cardiac Function, Lipid Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diet
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Fat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oxford Centre for Diabetes, Endocrinology and MetabolismRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High fat, high SFA

High fat, high UFA

Arm Description

~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA

~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA

Outcomes

Primary Outcome Measures

Liver fat
Changes in intrahepatic triglyceride, as measured by MRI

Secondary Outcome Measures

Postprandial plasma biochemistry
Changes in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal

Full Information

First Posted
March 20, 2023
Last Updated
July 18, 2023
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05962190
Brief Title
Short-term Fat Overfeeding on the Effects of Liver Metabolism
Acronym
FOS
Official Title
The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fat, Cardiac Function, Lipid Disorder, Adiposity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High fat, high SFA
Arm Type
Experimental
Arm Description
~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA
Arm Title
High fat, high UFA
Arm Type
Experimental
Arm Description
~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
High fat (~60% of total energy intake) diet enriched with either SFA or UFA
Primary Outcome Measure Information:
Title
Liver fat
Description
Changes in intrahepatic triglyceride, as measured by MRI
Time Frame
Pre- and after approx 28 days of consuming interventional diet
Secondary Outcome Measure Information:
Title
Postprandial plasma biochemistry
Description
Changes in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal
Time Frame
Pre- and after approx 28 days of consuming interventional diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leanne Hodson
Phone
01865 857224
Email
leanne.hodson@ocdem.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Hodson, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Centre for Diabetes, Endocrinology and Metabolism
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leanne Hodson
Phone
01865 857224
Email
leanne.hodson@ocdem.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Leanne Hodson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Short-term Fat Overfeeding on the Effects of Liver Metabolism

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