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Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

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ClinicalTrials.gov Identifier: NCT03090347
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
NAFLD Nutrient; Excess Other: Overconsumption of specific dietary nutrient Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Intervention Details:
  • Other: Overconsumption of specific dietary nutrient
    Subjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess.


Primary Outcome Measures :
  1. Liver de novo lipogenesis [ Time Frame: Within 21 days after starting the intervention diet ]
    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


Secondary Outcome Measures :
  1. Adipose tissue metabolism [ Time Frame: Within 21 days after starting the intervention diet ]
    Investigators will measure the change in the expression of key lipogenic genes in subcutaneous adipose tissue

  2. Liver fat accumulation [ Time Frame: Within 21 days after starting the intervention diet ]
    Investigators will measure the change in the amount of fat within the liver using MRI/S



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090347


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

Locations
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United Kingdom
Oxford Centre for Diabetes, Endocrinology and Metabolism Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Louise Dennis, MSc    +441865 857 203    louise.dennis@ocdem.ox.ac.uk   
Contact: Rachel Craven-Todd    +441865857331    rachel.craven-todd@ocdem.ox.ac.uk   
Principal Investigator: Leanne Hodson, PhD         
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03090347     History of Changes
Other Study ID Numbers: Oxlip-2017-BBSRC/BHF
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nutrients
Growth Substances
Physiological Effects of Drugs