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Inter Individual Variation in Weight Loss Response to Exercise

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Appetite, Body composition, Energy compensation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 25<BMI<35 Kg/m2
  • weight stable on the last three months (<2kg)
  • not currently dieting to lose weight
  • with an inactive lifestyle (not engaged in strenuous work or in regular brisk leisure time exercise more than once a week or in light exercise for more than 20 minutes/day in more than 3 times/week)

Exclusion Criteria:

  • History of endocrine/cardiovascular/pulmonary/kidney disease, anaemia, gout, depression or other psychological disorders
  • Eating disorders
  • Drug or alcohol abuse within the last two years
  • Current medication known to affect appetite or induce weight loss.
  • Those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise

Arm Description

Outcomes

Primary Outcome Measures

Changes in fasting and postprandial plasma levels of appetite related hormones

Secondary Outcome Measures

Changes in body weight and body composition

Full Information

First Posted
October 15, 2008
Last Updated
February 5, 2015
Sponsor
Norwegian University of Science and Technology
Collaborators
Fundação para a Ciência e a Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT00773214
Brief Title
Inter Individual Variation in Weight Loss Response to Exercise
Official Title
Identification and Characterization of Individual Variability in Exercise-induced Weight Loss: Biological and Behavioral Markers of Success.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Fundação para a Ciência e a Tecnologia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Appetite, Body composition, Energy compensation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
12-week supervised exercise programme (5 times /week at 75% maximal Heart Rate)
Primary Outcome Measure Information:
Title
Changes in fasting and postprandial plasma levels of appetite related hormones
Time Frame
Baseline and after a 12 week exercise intervention
Secondary Outcome Measure Information:
Title
Changes in body weight and body composition
Time Frame
Baseline and after a 12-week exercise intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 25<BMI<35 Kg/m2 weight stable on the last three months (<2kg) not currently dieting to lose weight with an inactive lifestyle (not engaged in strenuous work or in regular brisk leisure time exercise more than once a week or in light exercise for more than 20 minutes/day in more than 3 times/week) Exclusion Criteria: History of endocrine/cardiovascular/pulmonary/kidney disease, anaemia, gout, depression or other psychological disorders Eating disorders Drug or alcohol abuse within the last two years Current medication known to affect appetite or induce weight loss. Those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catia Martins, BSc, MSc, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7030
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20150577
Citation
Martins C, Kulseng B, King NA, Holst JJ, Blundell JE. The effects of exercise-induced weight loss on appetite-related peptides and motivation to eat. J Clin Endocrinol Metab. 2010 Apr;95(4):1609-16. doi: 10.1210/jc.2009-2082. Epub 2010 Feb 11.
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Inter Individual Variation in Weight Loss Response to Exercise

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