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Not Yet Recruiting NCT05643521

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

Conditions: NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes

Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 14
Sponsor: Hvidovre University Hospital

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.

Eligibility Criteria

Inclusion Criteria:Men (30-75 years) and postmenopausal women 45-75 years oldHba1c <48 mmol/mol without antidiabetic treatmentObese (BMI 27-40 kg/m2)Non smokersExclusion Criteria:Anemia (hemoglobin <8 mmol/L for men and <7 mmol/L for women)TSH outside reference rangeMedication known to influence glucose metabolism or appetite regulationContraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobiaFood allergies (including lactose and gluten intolerance), vegetarian/vegan diet or following specific dietary plansAlcohol 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 surgeryHigh risk of fibrosis of the liver (estimated by FIB4 score > 3,25)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05643521). StuddyBuddy aggregates publicly available trial information.