The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content

NCT04581421 | Completed

• 1 other identifier: LICARB ID PhD010-19.
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.

Conditions

NAFLD; Overweight and Obesity; Metabolic Syndrome; Diabetes

Outcome Measures

Primary Outcomes (1)

• Liverfat

  The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.

  (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)

Secondary Outcomes (4)

• Glycogen

  (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)

• fasting hepatic glucose output

  (Day 0 and Day 6 of the diet intervention)

• fasting blood triacylglycerol concentration

  (Day 0 and Day 6 of the diet intervention)

• Insulin clearance determined during steady state insulin infusion

  (Day 0 and Day 6 of the diet intervention)

Study Arms (2)

High Carb first

EXPERIMENTAL

Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet

Low Carb first

EXPERIMENTAL

Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet

Interventions

High Carb Low Fat Diet OTHER

The participants will be randomized to a diet of low carb/ high fat og high carb/low fat

High Carb first; Low Carb first

Low Carb High Fat Diet OTHER

The participants will be randomized to a diet of low carb/ high fat og high carb/low fat

High Carb first; Low Carb first

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men being 18-50 years old.
• Overweight (BMI 25-35)
• Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise.
• Non-smokers
• No use of medicine

You may not qualify if:

• Fasting blood glucose indicating overt diabetes (≥7 mmol/l)
• HbA1C \>48 mmol/mol
• Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l)
• FIB-4 score \>1.45
• Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Danish Research Centre for Magnetic Resonance: collaborator

Study Sites (1)

Amalie London

Hvidovre, Denmark

Location

Related Publications (1)

• London A, Richter MM, Sjoberg KA, Wewer Albrechtsen NJ, Povazan M, Drici L, Schaufuss A, Madsen L, Oyen J, Madsbad S, Holst JJ, van Hall G, Siebner HR, Richter EA, Kiens B, Lundsgaard A, Bojsen-Moller KN. The impact of short-term eucaloric low- and high-carbohydrate diets on liver triacylglycerol content in males with overweight and obesity: a randomized crossover study. Am J Clin Nutr. 2024 Aug;120(2):283-293. doi: 10.1016/j.ajcnut.2024.06.006. Epub 2024 Jun 22.

  PMID: 38914224 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Overweight; Obesity; Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD

Model Details: Randomized diet intervention study in a cross over design

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 9, 2020
• Study Start: December 3, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

DK (1)