The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals

NCT05643521 | Unknown

• 1 other identifier: FixedCarb - H-22035189
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of this study is to investigate the acute changes in liver fat content in response to a fixed carbohydrate restriction (i.e. intake of 60g/day or 70g/day for women and men, respectively) in individuals with obesity. This will be performed both as 2 days of very low calorie diet (500 and 600 kcal/day for women and men, respectively) and 2 days of eucaloric low carbohydrate diet.

Conditions

NAFLD; Overweight and Obesity; Metabolic Syndrome; Diabetes

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.

  We will compare MRS of liver TG after each of the two interventions (2 days of VLCD or 2 days of LC) with MRS liver TG obtained after 2 days of eucaloric conventional diet.

  After 2 days completion of dietary intervention

Secondary Outcomes (1)

• Secondary outcomes are fasting and postprandial plasma glucose, insulin, and plasma TG concentrations after 2 days VLCD or LC compared with 2 days of eucaloric conventional diet.

  After 2 days completion of dietary intervention

Other Outcomes (1)

• Explorative outcomes

  After 2 days completion of dietary intervention

Study Arms (3)

Control Arm

EXPERIMENTAL

2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)

Other: Dietary composition of macronutrients and calories

Hypocaloric low carbohydrate

EXPERIMENTAL

2 days of eucaloric control diet + 2 days of hypocaloric (500-600 kcal m/f) low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.

Other: Dietary composition of macronutrients and calories

Eucaloric low carbohydrate

EXPERIMENTAL

2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.

Other: Dietary composition of macronutrients and calories

Interventions

Dietary composition of macronutrients and calories OTHER

Carbohydrate restriction

Control Arm; Eucaloric low carbohydrate; Hypocaloric low carbohydrate

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men (30-75 years) and postmenopausal women 45-75 years old
• Hba1c \<48 mmol/mol without antidiabetic treatment
• Obese (BMI 27-40 kg/m2)
• Non smokers

You may not qualify if:

• Anemia (hemoglobin \<8 mmol/L for men and \<7 mmol/L for women)
• TSH outside reference range
• Medication known to influence glucose metabolism or appetite regulation
• Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
• Food allergies (including lactose and gluten intolerance), vegetarian/vegan diet or following specific dietary plans
• Alcohol consumptions \>84/168 g/week (women/men)
• Strenuous activity level \> 120 minutes per week
• \>5 kg weight loss within the last three months or previous bariatric surgery
• High risk of fibrosis of the liver (estimated by FIB4 score \> 3,25)

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Nutrition Exercise and sports Copenhagen University: collaborator

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 Affiliation: Hvidovre University Hospital

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

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 8, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 8, 2022

Record last verified: 2022-12