Inter Individual Variation in Weight Loss Response to Exercise
| Tracking Information | |||||
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| First Received Date ICMJE | October 15, 2008 | ||||
| Last Updated Date | April 9, 2013 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in fasting and postprandial plasma levels of appetite related hormones [ Time Frame: Baseline and after a 12 week exercise intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00773214 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes in body weight and body composition [ Time Frame: Baseline and after a 12-week exercise intervention ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Inter Individual Variation in Weight Loss Response to Exercise | ||||
| Official Title ICMJE | Identification and Characterization of Individual Variability in Exercise-induced Weight Loss: Biological and Behavioral Markers of Success. | ||||
| Brief Summary | The identification and characterization of individuals who vary in their response to exercise-induced weight loss is important. Weight loss in response to exercise is variable and it remains unknown who will succeed, why, and more importantly how to improve weight loss efficacy. This study will examine changes in behavioural, metabolic, physiological and biochemical variables in response to a 12 week supervised exercise programme and evaluate their association with weight loss in overweight and obese sedentary individuals. Our hypothesis is that changes in the plasma levels of appetite related hormones undermine the inter individual variation in weight loss in response to exercise. This study will improve the understanding of variability to exercise-induced weight loss and allow more individually tailored and appropriate strategies for weight management programmes. |
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| Detailed Description | Purpose - To identify predictors of weight loss in overweigh/obese volunteers following a 12 week supervised exercise programme, and to characterise the variability in weight loss response. Method - Longitudinal study aiming to identify predictors of weight loss in response to a 12-week exercise programme in healthy overweight/obese volunteers. Subjective and objective measures of appetite, cardiovascular fitness, anthropometry, body composition, resting metabolic rate (RMR), fat and carbohydrate oxidation in the fasting state will be measured at baseline, before participants enroll for the study and after the exercise intervention. The preload/test-meal paradigm (using a high and low-energy preload: HEP vs LEP) will be used to assess short-term appetite control before and after the exercise intervention following a randomized single-blinded crossover design. Moreover, the long-term effects of exercise on cytokine plasma levels and fasting and postprandial levels of appetite related hormones/metabolites will also be assessed at baseline and end of the study. Participants will act as their own controls throughout the study. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: Exercise
12-week supervised exercise programme (5 times /week at 75% maximal Heart Rate) |
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| Study Arm (s) | Experimental: exercise
Intervention: Behavioral: Exercise |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 22 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00773214 | ||||
| Other Study ID Numbers ICMJE | 18926 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Norwegian University of Science and Technology | ||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||
| Collaborators ICMJE | Fundacao Ciencia e Tecnologia (Portugal) | ||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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