ClinicalTrials.gg
Status unknownNCT03090347Updated Jun 7, 2022

Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

An interventional study of Overconsumption of specific dietary nutrient in NAFLD and Nutrient; Excess, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-07.

Sponsored by University of Oxford · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

This research aims to investigate how the overconsumption of specific macronutrients may effect adipose tissue and liver metabolism and function. Liver and heart fat content and adipose tissue and liver metabolism fasting and postprandial lipid metabolism will be assessed before and after the specific dietary intervention.

02

Conditions studied

  • NAFLD
  • Nutrient; Excess
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • History of an eating disorder or any other psychological condition that may affect the participants ability to adhere to study intervention/experimental diets.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    High-sugar diet

    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

  • OtherOverconsumption of specific dietary nutrient

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

06

What researchers measure

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

    Time frame: Within 21 days after starting the intervention diet

Secondary outcomes

  1. Adipose tissue metabolism

    Investigators will measure the change in the expression of key lipogenic genes in subcutaneous adipose tissue

    Time frame: Within 21 days after starting the intervention diet

  2. Liver fat accumulation

    Investigators will measure the change in the amount of fat within the liver using MRI/S

    Time frame: Within 21 days after starting the intervention diet

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Mar 2023, 72 months after the start.

Of 323 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 72 months is above that.

Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2017
First posted
Mar 24, 2017
StartActual
Mar 1, 2017
Primary completionEst.
Mar 31, 2023
CompletionEst.
Mar 31, 2023
Last update
Jun 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03090347
Responsible party
Sponsor
First posted
Mar 24, 2017
Start date
Mar 1, 2017
Primary completion
Mar 31, 2023 (estimated)
Completion
Mar 31, 2023 (estimated)
Last update
Jun 7, 2022

Study contacts

Leanne Hodson, PhD
Contact
leanne.hodson@ocdem.ox.ac.uk
+441865857224

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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