Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

NAFLD Clinical Trial

Official title:

The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090347
• Other study ID #: Oxlip-2017-BBSRC/BHF
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: University of Oxford
• Contact: Leanne Hodson, PhD
• Phone: +441865857224
• Email: leanne.hodson[@]ocdem.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• NAFLD
• Nutrient; Excess

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Oxford Centre for Diabetes, Endocrinology and Metabolism	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adipose tissue metabolism	Investigators will measure the change in the expression of key lipogenic genes in subcutaneous adipose tissue	Within 21 days after starting the intervention diet
Secondary	Liver fat accumulation	Investigators will measure the change in the amount of fat within the liver using MRI/S	Within 21 days after starting the intervention diet