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

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ClinicalTrials.gov Identifier: NCT05643521
Recruitment Status : Not yet recruiting
First Posted : December 8, 2022
Last Update Posted : December 8, 2022
Sponsor:
Collaborators:
University of Copenhagen Danish Research Centre for Magnetic Resonance
Nutrition Exercise and sports Copenhagen University
Information provided by (Responsible Party):
Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
NAFLD Overweight and Obesity Metabolic Syndrome Diabetes Other: Dietary composition of macronutrients and calories Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment Randomized diet intervention study in a cross over design
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control Arm
2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)
Other: Dietary composition of macronutrients and calories
Carbohydrate restriction

Experimental: Hypocaloric low carbohydrate
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
Carbohydrate restriction

Experimental: Eucaloric low carbohydrate
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
Carbohydrate restriction




Primary Outcome Measures :
  1. The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content. [ Time Frame: After 2 days completion of dietary intervention ]
    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 :
  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. [ Time Frame: After 2 days completion of dietary intervention ]

Other Outcome Measures:
  1. Explorative outcomes [ Time Frame: After 2 days completion of dietary intervention ]
    Explorative outcomes are the effects of VLCD and LC on subsequent food intake in response to an ad libitum lunch meal.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
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Responsible Party: Kirstine Nyvold Bojsen-Moeller, Principal investigator, MD, PhD Affiliation: Hvidovre University Hospital, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT05643521    
Other Study ID Numbers: FixedCarb - H-22035189
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases