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

Sponsor
University of Oxford (Other)
Overall Status
Recruiting
CT.gov ID
NCT05962190
Collaborator
(none)
26
1
2
59.5
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.
Actual Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Feb 1, 2028
Anticipated Study Completion Date :
Feb 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Liver fat [Pre- and after approx 28 days of consuming interventional diet]

    Changes in intrahepatic triglyceride, as measured by MRI

Secondary Outcome Measures

  1. Postprandial plasma biochemistry [Pre- and after approx 28 days of consuming interventional diet]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford Centre for Diabetes, Endocrinology and Metabolism Oxford United Kingdom OX3 7LE

Sponsors and Collaborators

  • University of Oxford

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT05962190
Other Study ID Numbers:
  • 211172
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023