BoLD: Blood Lipid Responses to Diet

Sponsor
University of Oxford (Other)
Overall Status
Recruiting
CT.gov ID
NCT05973539
Collaborator
(none)
60
2
2
58.5
30
0.5

Study Details

Study Description

Brief Summary

The macronutrient composition of our diet (proportions of carbohydrates, fats and proteins) strongly influences the way our body stores and utilises substrates (e.g., fats and sugars), which in turn influences our 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet
N/A

Detailed Description

Dietary and lifestyle interventions are central to lowering the risk and preventing the development of metabolic disease, including non-alcoholic fatty liver disease, type 2 diabetes, and cardiovascular disease. There is, however, no one fits all dietary approach, and in the context of diets where an individual is not gaining or losing weight (known as eucaloric), the optimal macronutrient composition associated with a reduced risk of metabolic disease and dyslipidemia is highly debated. For instance, eating less of one macronutrient implies eating more of another; a reduction in the intake of dietary carbohydrates is met by an increase in dietary fats. How this affects one's metabolic health in the setting when someone is not gaining or losing body weight is unclear.

Therefore, this study aims to provide an understanding of the effect that the quantity of specific dietary macronutrients (e.g., carbohydrates, fats) have on plasma triglyceride concentrations in both the fasting and postprandial state, liver fat content and metabolism, and cardiac fat content and function.

Sixty volunteers free from metabolic disease will be recruited into a randomized, parallel-armed dietary intervention study. Participants will consume either a low carbohydrate, high-fat diet or a high carbohydrate, low-fat diet for up to 28 days. Diets will be eucaloric (i.e., designed to meet the individual participant's energy requirements). Comprehensive in vivo metabolic and physiological testing will be performed before and after the experimental diet to document the effects of the overconsumption of specific macronutrients (i.e., fats or carbohydrates) on liver and lipid metabolism.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Investigating Blood Lipid Responses to Dietary Macronutrient Content
Actual Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Jan 1, 2028
Anticipated Study Completion Date :
Jan 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: High carbohydrate, low fat diet

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

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

Experimental: High fat, low carbohydrate diet

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in plasma triglyceride concentrations [mmol/L] [Pre- and post-diet [21-28 days]]

    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.

Secondary Outcome Measures

  1. Change in liver fat content [%] [Pre- and post-diet [21-28 days]]

    Liver fat content (intra-hepatic triglyceride) will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy

  2. Change in cardiac fat content [%] [Pre- and post-diet [21-28 days]]

    Cardiac fat content will be measured before and at the end of the dietary intervention by magnetic resonance imaging/spectroscopy

  3. 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]]

    Through measuring the incorporation of [13C]palmitate and [2H2]palmitate in isolated plasma VLDL during a mixed-macronutrient feeding test.

  4. Change in hepatic fatty acid synthesis [Pre- and post-diet [21-28 days]]

    Measured by incorporation of [2H2] palmitate from 2H2O into VLDL-triglyceride

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford Oxford United Kingdom OX3 7LE
2 Oxford Centre for Diabetes, Endocrinology and Metabolism Oxford United Kingdom OX3 7LE

Sponsors and Collaborators

  • University of Oxford

Investigators

  • Principal Investigator: Leane Hodson, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT05973539
Other Study ID Numbers:
  • 316098
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023