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Low Calorie Diet in Morbidly Obese Patients

Effect of 6 Days Low Calorie Diet Before Bariatric Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02671279
Acronym
PreBar
Enrollment
15
Registered
2016-02-02
Start date
2016-08-31
Completion date
2019-12-31
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTLow calorie diet

6 days of low calorie diet, estimated kcal 400-600/day.

Sponsors

Helse Fonna
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* BMI 40-46 kg/m2 * The patients must not conduct a diet before admission. * Fasting blood glucose \<-7 nmol/l

Exclusion criteria

* Diabetes mellitus * Treatment with antidiabetics * Allergy for substances in the planned study-diet

Design outcomes

Primary

MeasureTime frame
Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet8 days

Secondary

MeasureTime frame
Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet8 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026