Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism
The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism
1 other identifier
interventional
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJune 7, 2022
April 1, 2022
6.1 years
March 20, 2017
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
EXPERIMENTALParticipants will be asked to consume a relatively low-fat, high-carbohydrate eucaloric diet enriched in free-sugars (20% total energy).
Interventions
Subjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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.