NCT05962190

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Feb 2023Feb 2028

Study Start

First participant enrolled

February 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

July 27, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

March 20, 2023

Last Update Submit

July 18, 2023

Conditions

Liver FatCardiac FunctionLipid DisorderAdiposity

Outcome Measures

Primary Outcomes (1)

  • Liver fat

    Changes in intrahepatic triglyceride, as measured by MRI

    Pre- and after approx 28 days of consuming interventional diet

Secondary Outcomes (1)

  • Postprandial plasma biochemistry

    Pre- and after approx 28 days of consuming interventional diet

Study Arms (2)

High fat, high SFA

EXPERIMENTAL

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

Behavioral: Diet

High fat, high UFA

EXPERIMENTAL

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

Behavioral: Diet

Interventions

DietBEHAVIORAL

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

High fat, high SFAHigh fat, high UFA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX3 7LE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fatty LiverLipid Metabolism DisordersObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Leanne Hodson, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leanne Hodson

CONTACT

01865 857224leanne.hodson@ocdem.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

July 27, 2023

Study Start

February 15, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

July 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)