Back to resultsThe Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals (FixedCarb)
Primary Purpose
NAFLD, Overweight and Obesity, Metabolic Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary composition of macronutrients and calories
Sponsored by
About this trial
This is an interventional basic science trial for NAFLD
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control Arm
Hypocaloric low carbohydrate
Eucaloric low carbohydrate
Arm Description
2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)
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.
2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05643521
First Posted
November 22, 2022
Last Updated
December 1, 2022
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen Danish Research Centre for Magnetic Resonance, Nutrition Exercise and sports Copenhagen University
1. Study Identification
Unique Protocol Identification Number
NCT05643521
Brief Title
The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
Acronym
FixedCarb
Official Title
The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen Danish Research Centre for Magnetic Resonance, Nutrition Exercise and sports Copenhagen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment Randomized diet intervention study in a cross over design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)
Arm Title
Hypocaloric low carbohydrate
Arm Type
Experimental
Arm Description
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.
Arm Title
Eucaloric low carbohydrate
Arm Type
Experimental
Arm Description
2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.
Intervention Type
Other
Intervention Name(s)
Dietary composition of macronutrients and calories
Intervention Description
Carbohydrate restriction
Primary Outcome Measure Information:
Title
The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
Description
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.
Time Frame
After 2 days completion of dietary intervention
Secondary Outcome Measure Information:
Title
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.
Time Frame
After 2 days completion of dietary intervention
Other Pre-specified Outcome Measures:
Title
Explorative outcomes
Description
Explorative outcomes are the effects of VLCD and LC on subsequent food intake in response to an ad libitum lunch meal.
Time Frame
After 2 days completion of dietary intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
12. IPD Sharing Statement
Learn more about this trial
The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
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