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

NCT ID: NCT05643521

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Overweight and Obesity Metabolic Syndrome Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment Randomized diet intervention study in a cross over design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control Arm

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

Group Type EXPERIMENTAL

Dietary composition of macronutrients and calories

Intervention Type OTHER

Carbohydrate restriction

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.

Group Type EXPERIMENTAL

Dietary composition of macronutrients and calories

Intervention Type OTHER

Carbohydrate restriction

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.

Group Type EXPERIMENTAL

Dietary composition of macronutrients and calories

Intervention Type OTHER

Carbohydrate restriction

Interventions

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Dietary composition of macronutrients and calories

Carbohydrate restriction

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen Danish Research Centre for Magnetic Resonance

UNKNOWN

Sponsor Role collaborator

Nutrition Exercise and sports Copenhagen University

UNKNOWN

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kirstine Nyvold Bojsen-Moeller

Principal investigator, MD, PhD Affiliation: Hvidovre University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FixedCarb - H-22035189

Identifier Type: -

Identifier Source: org_study_id