search
Back to results

Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Gastric bypass
Caloric restriction
Sponsored by
KiloCoach e.U.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Caloric restriction, Obesity, Gastric bypass, Resting metabolic rate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Barmherzige Schwestern Vienna
  • KiloCoach e.U.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Gastric bypass

Caloric restriction

Arm Description

Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate.

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.

Outcomes

Primary Outcome Measures

Resting metabolic rate

Secondary Outcome Measures

Body composition (muscle mass, fat mass)
Body Mass Index
Caloric restriction
Weight loss

Full Information

First Posted
May 9, 2012
Last Updated
February 4, 2015
Sponsor
KiloCoach e.U.
Collaborators
Hospital Barmherzige Schwestern Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT01595945
Brief Title
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate
Official Title
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KiloCoach e.U.
Collaborators
Hospital Barmherzige Schwestern Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Caloric restriction, Obesity, Gastric bypass, Resting metabolic rate

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric bypass
Arm Type
Other
Arm Description
Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate.
Arm Title
Caloric restriction
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gastric bypass
Intervention Description
Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction
Intervention Description
Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.
Primary Outcome Measure Information:
Title
Resting metabolic rate
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Body composition (muscle mass, fat mass)
Time Frame
24 weeks
Title
Body Mass Index
Time Frame
24 weeks
Title
Caloric restriction
Time Frame
24 weeks
Title
Weight loss
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Aspalter, MD.
Organizational Affiliation
KiloCoach e.U.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Barmherzige Schwestern Vienna
City
Vienna
ZIP/Postal Code
1060
Country
Austria
Facility Name
KiloCoach e.U.
City
Vienna
ZIP/Postal Code
1060
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate

We'll reach out to this number within 24 hrs