Inter Individual Variation in Weight Loss Response to Exercise

This study has been completed.
Sponsor:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00773214
First received: October 15, 2008
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Identification and Characterization of Individual Variability in Exercise-induced Weight Loss: Biological and Behavioral Markers of Success.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in body weight and body composition [ Time Frame: Baseline and after a 12-week exercise intervention ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise Behavioral: Exercise
12-week supervised exercise programme (5 times /week at 75% maximal Heart Rate)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773214

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
Fundação para a Ciência e a Tecnologia
Investigators
Principal Investigator: Catia Martins, BSc, MSc, PhD Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00773214     History of Changes
Other Study ID Numbers: 18926
Study First Received: October 15, 2008
Last Updated: April 9, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Obesity
Appetite
Body composition
Energy compensation

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014