Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

February 4, 2015 updated by: KiloCoach e.U.

Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects

Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. The purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1060
        • Hospital Barmherzige Schwestern Vienna
      • Vienna, Austria, 1060
        • KiloCoach e.U.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥30 kg/m2

Exclusion Criteria:

  • Marked weight reduction in the last 2 years (>5% of initial body weight)
  • Recent extreme fasting (during the last month)
  • Manifest eating disorders (assignment to a specialist for eating disorders)
  • Severe psychiatric disorders requiring treatment
  • Pregnancy, lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Gastric bypass
Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate.
Procedure: Gastric bypass
Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.
OTHER: Caloric restriction
Caloric restriction calculated by an online weight management program (based on subject's starting weight, start BMI, age, target weight and time span). Subjects are followed-up in regard to resting metabolic rate.
Behavioral: Caloric restriction
Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting metabolic rate
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition (muscle mass, fat mass)
Time Frame: 24 weeks
24 weeks
Body Mass Index
Time Frame: 24 weeks
24 weeks
Caloric restriction
Time Frame: 24 weeks
24 weeks
Weight loss
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KiloCoach e.U.

Collaborators

Hospital Barmherzige Schwestern Vienna

Investigators

  • Study Director: Rosa Aspalter, MD., KiloCoach e.U.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (ESTIMATE)

May 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCKBHS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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