Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate
This study is currently recruiting participants.
Verified May 2012 by KiloCoach e.U.
Sponsor:
KiloCoach e.U.
Collaborator:
Hospital Barmherzige Schwestern Vienna
Information provided by (Responsible Party):
KiloCoach e.U.
ClinicalTrials.gov Identifier:
NCT01595945
First received: May 9, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Procedure: Gastric bypass Behavioral: Caloric restriction |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects |
Resource links provided by NLM:
Further study details as provided by KiloCoach e.U.:
Primary Outcome Measures:
- Resting metabolic rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Body composition (muscle mass, fat mass) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Body Mass Index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Caloric restriction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595945
Contacts
| Contact: Rita Longin | 004315861316 ext 17 | rita.longin@kilocoach.at |
Locations
| Austria | |
| KiloCoach e.U. | Recruiting |
| Vienna, Austria, 1060 | |
| Contact: Rita Longin 004315861316 ext 17 rita.longin@kilocoach.at | |
| Principal Investigator: Rosa Aspalter, MD. | |
| Sub-Investigator: Rita Longin | |
| Hospital Barmherzige Schwestern Vienna | Recruiting |
| Vienna, Austria, 1060 | |
| Contact: Alexander Klaus, MD. 0043159988 ext 6201 alexander.klaus@bhs.at | |
| Principal Investigator: Alexander Klaus, MD. | |
Sponsors and Collaborators
KiloCoach e.U.
Hospital Barmherzige Schwestern Vienna
Investigators
| Study Director: | Rosa Aspalter, MD. | KiloCoach e.U. |
More Information
Additional Information:
No publications provided
| Responsible Party: | KiloCoach e.U. |
| ClinicalTrials.gov Identifier: | NCT01595945 History of Changes |
| Other Study ID Numbers: | KCKBHS-01 |
| Study First Received: | May 9, 2012 |
| Last Updated: | May 9, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by KiloCoach e.U.:
|
Caloric restriction Obesity Gastric bypass Resting metabolic rate |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013