Status:
COMPLETED
Dietary Carbohydrate and Internal Body Fat
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
University of Bergen
Conditions:
Adiposity
Eligibility:
All Genders
20-55 years
Phase:
NA
Brief Summary
This is a 2-year randomized controlled trial to test the effect of dietary carbohydrates, both quality and quantity, on changes in internal body fat mass. Up to 250 women and men with obesity are recr...
Detailed Description
Obesity, and high internal fat storage in particular, represents a tremendous and increasing health challenge across the world, and is linked to the recent introduction and globalization of an ultra-p...
Eligibility Criteria
Inclusion
- Body-mass index (BMI) equal to or above 30 kg/m2 and/or waist circumference equal to or above 102 cm for men and 88 cm for women
- Weight stable during the last 2 months before start of the study (less than 5 % change in body weight up or down)
- No known diabetes or consumption of diabetes medication
- Desire to follow a specified dietary pattern using specific recipes throughout the time of the study period
- Ability to periodically record food intake using a specially designed app for the study
Exclusion
- Use of statins and/or diabetes medication
- Recent surgical or antibiotics treatment during the last 2 months before start of the study
- Chronic inflammatory bowel disease
- Serious disease
- Smoking
- Pregnancy or breast feeding
- Alcohol consumption during the study of more than 2 alcohol units per day (1 unit = 15 ml (12.8 g) pure alcohol)
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03401970
Start Date
January 3 2018
End Date
March 24 2021
Last Update
April 26 2021
Active Locations (1)
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1
Forskningsenhet for helseundersøkelser (research unit for clinical trials), Department of Clinical Science, University of Bergen
Bergen, Norway, 5021