Low Calorie Diet in Morbidly Obese Patients (PreBar)
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|ClinicalTrials.gov Identifier: NCT02671279|
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Low calorie diet||Not Applicable|
The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.
At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period.
During the operation fatty tissue samples will be taken subcutaneous and from the omentum major.
This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of 6 Days Low Calorie Diet Before Bariatric Surgery|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||December 2019|
Low calorie diet
Dietary intervention group
Dietary Supplement: Low calorie diet
6 days of low calorie diet, estimated kcal 400-600/day.
- Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet [ Time Frame: 8 days ]
- Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet [ Time Frame: 8 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671279
|Haukeland University Hospital|
|Bergen, Hordaland, Norway, 5020|
|Haugesund Sjukehus, Helse Fonna|
|Principal Investigator:||Gunnar Mellgren, MD, PhD||Haukeland University Hospital|