- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03090347
Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism
June 6, 2022 updated by: University of Oxford
The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Leanne Hodson, PhD
- Phone Number: +441865857224
- Email: leanne.hodson@ocdem.ox.ac.uk
Study Locations
-
-
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Oxford, United Kingdom, OX3 7LE
- Recruiting
- Oxford Centre for Diabetes, Endocrinology and Metabolism
-
Contact:
- Rachel Craven-Todd
- Phone Number: +441865857331
- Email: rachel.craven-todd@ocdem.ox.ac.uk
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Principal Investigator:
- Leanne Hodson, PhD
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Contact:
- Louise Dennis, MSc
- Phone Number: +441865 857 203
- Email: louise.dennis@ocdem.ox.ac.uk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
Subjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver de novo lipogenesis
Time Frame: Within 21 days after starting the intervention diet
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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
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Within 21 days after starting the intervention diet
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adipose tissue metabolism
Time Frame: Within 21 days after starting the intervention diet
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Investigators will measure the change in the expression of key lipogenic genes in subcutaneous adipose tissue
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Within 21 days after starting the intervention diet
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Liver fat accumulation
Time Frame: Within 21 days after starting the intervention diet
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Investigators will measure the change in the amount of fat within the liver using MRI/S
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Within 21 days after starting the intervention diet
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Anticipated)
March 31, 2023
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
March 20, 2017
First Submitted That Met QC Criteria
March 20, 2017
First Posted (Actual)
March 24, 2017
Study Record Updates
Last Update Posted (Actual)
June 7, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Oxlip-2017-BBSRC/BHF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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