NCT03090347

Brief Summary

In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary fat then this increases the chance of it being stored in the liver, which is related to increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet high in sugars or certain fats, may cause the fat tissue and liver to change how they function; we would like to investigate this in detail.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

June 7, 2022

Status Verified

April 1, 2022

Enrollment Period

6.1 years

First QC Date

March 20, 2017

Last Update Submit

June 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Liver de novo lipogenesis

    Investigators will utilise stable isotope tracer methodology to measure the change in the contribution of newly synthesised fatty acids to very low density lipoprotein triglyceride

    Within 21 days after starting the intervention diet

Secondary Outcomes (2)

  • Adipose tissue metabolism

    Within 21 days after starting the intervention diet

  • Liver fat accumulation

    Within 21 days after starting the intervention diet

Study Arms (1)

High-sugar diet

EXPERIMENTAL

Participants will be asked to consume a relatively low-fat, high-carbohydrate eucaloric diet enriched in free-sugars (20% total energy).

Other: Overconsumption of specific dietary nutrient

Interventions

Subjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess.

High-sugar diet

Eligibility Criteria

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

You may qualify if:

  • 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 known to affect liver or adipose tissue metabolism.
  • Weight stable for the previous 3 months

You may not qualify if:

  • Patient is unwilling or unable to give informed consent for participation in the study
  • A 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 who are taking 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, pacemaker, 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

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

March 1, 2017

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

June 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Following completion of the study, all individual data obtained from participants may potentially be shared with other researchers, both here in the United Kingdom and abroad, in appropriate circumstances. If data is to be shared with other researchers, it will be done so under fully anonymised conditions.

Locations