Blood Lipid Responses to Diet Macronutrients

NCT05973539 | Recruiting

• 1 other identifier: 316098
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The macronutrient composition of a diet (proportions of carbohydrates, fats and proteins) strongly influences the way the body stores and utilises substrates (e.g., fats and sugars), which in turn influences the risk of developing cardiometabolic diseases (e.g., coronary artery disease or insulin resistance). The optimal dietary composition to lower the risk of cardiometabolic disease is unknown. In a randomized, parallel design, this study will investigate how the overconsumption of carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from metabolic disease. By genotyping participants, the interaction between macronutrient content and an individual's genes on blood lipid responses and liver metabolism will be examined.

Conditions

Nutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Change in plasma triglyceride concentrations [mmol/L]

  Change in plasma triglyceride concentrations in response to consumption of macronutrient meal will be measured by basic clinical chemistry before and at the end of the dietary intervention.

  Pre- and post-diet [21-28 days]

Secondary Outcomes (5)

• Change in liver fat content [%]

  Pre- and post-diet [21-28 days]

• Change in cardiac fat content [%]

  Pre- and post-diet [21-28 days]

• Change in the contribution of dietary and adipose tissue derived fatty acids to very low density lipoprotein-triglyceride (VLDL-TG) palmitate

  Pre- and post-diet [21-28 days]

• Change in hepatic fatty acid synthesis

  Pre- and post-diet [21-28 days]

• Influence of genotype on the change in plasma lipid content [mmol/L]

  Pre- and post-diet [21-28 days]

Study Arms (2)

High carbohydrate, low fat diet

EXPERIMENTAL

65% of energy is derived from carbohydrates, 20% from fat, and 15% from protein.

Other: Diet

High fat, low carbohydrate diet

EXPERIMENTAL

65% of energy is derived from fat, 20% from carbohydrates, and 15% from protein.

Other: Diet

Interventions

Diet OTHER

Eucaloric diet enriched in either carbohydrates or fat (both contributing to 65% total energy intake)

High carbohydrate, low fat diet; High fat, low carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged ≥18 to ≤65 years
• Body mass index (BMI) ≥19 to ≤35 kg/m2
• No medical condition or relevant drug therapy that is known to affect the liver, adipose tissue, or cardiac metabolism.
• Weight stable for the previous 3 months

You may not qualify if:

• Aged \<18 or \>65 years
• BMI \<19 or \>35 kg/m2
• A blood haemoglobin \<135 mg/dL for men and \<120 mg/dL for women
• Donated (or lost) ≥250 mL of blood in the previous two months
• On a weight loss diet or decreased their body weight by \>5% in the previous 3 months
• Currently adhering to or have consumed in the previous 3 months a diet with a notably altered macro-nutrient content (e.g. high-fat - low-carbohydrate diet)
• 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)
• History of albumin allergy.
• Pregnant or nursing mothers
• History of severe claustrophobia

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford

Oxford, OX3 7LE, United Kingdom

RECRUITING

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX3 7LE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Leane Hodson

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Dearlove

CONTACT

07739460623; david.dearlove@ocdem.ox.ac.uk

Leane Hodson

CONTACT

leanne.hodson@ocdem.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: August 3, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)