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Impaired Regulation of Energy Balance in Elderly People (Balance Study) (Balance)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561145
First Posted: November 20, 2007
Last Update Posted: March 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dutch Dairy Organization (NZO)
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
  Purpose

Over the past century life expectancy has risen rapidly. As a result, the proportion of elderly people continues to grow. Elderly people probably have an impaired regulation of energy balance (energy intake versus energy expenditure) whereby the underlying physiological mechanisms are not fully understood.

The first objective of this study is to provide further evidence for an age-related failure to regulate energy balance in elderly. If the hypothesis of impaired regulation of energy balance in elderly is confirmed then the second objective becomes to elucidate the underlying physiological mechanisms of the age-related failure to regulate energy intake in elderly.


Condition Intervention
Anorexia of Ageing Other: Energy restriction period

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.

Further study details as provided by Lisette de Groot, Wageningen University:

Primary Outcome Measures:
  • Energy Intake Compensation [ Time Frame: Average intake of energy during ad lib phase (9 days) ]

    To assess energy intake compensation, we will assess average energy intake during the ad libitum food intake phase - which is the period after energy restriction- in young men and compare this to average energy intake in older men.

    Average energy intake is assessed by measuring total megajoule of energy intake during nine days of the ad lib phase, and then divide it by nine (MJ/day)



Secondary Outcome Measures:
  • Appetite/Satiety Hormones and Questionnaires [ Time Frame: Before and after the energy restriction period. ]
  • Gastrointestinal Function [ Time Frame: Before and after the energy restriction period ]
  • Resting Energy Expenditure, Body Composition and Body Weight [ Time Frame: Before and after the energy restriction period ]
  • Expression of Genes Involved in Energy Metabolism [ Time Frame: Before and after the energy restriction period. ]

Enrollment: 32
Study Start Date: October 2007
Study Completion Date: March 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Young men
Energy restriction period
Other: Energy restriction period
The experiment can be divided in 3 phases, namely (1) run-in phase, (2) energy restriction phase and (3) ad libitum food intake phase. Thus, for all participants the experiment consists of three subsequent phases.
Experimental: Elderly men
Energy restriction period
Other: Energy restriction period
The experiment can be divided in 3 phases, namely (1) run-in phase, (2) energy restriction phase and (3) ad libitum food intake phase. Thus, for all participants the experiment consists of three subsequent phases.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men
  • healthy
  • 20-40 and 65-85 years of age
  • normal weight
  • free-living in Wageningen and surrounding

Exclusion Criteria:

  • anemia
  • diabetes
  • restrained eating
  • dementia
  • weight changes of > 2 kg during the last 2 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561145


Locations
Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
Dutch Dairy Organization (NZO)
Investigators
Principal Investigator: Lisette de Groot, Prof, PhD Wageningen University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisette de Groot, Professor, Wageningen University
ClinicalTrials.gov Identifier: NCT00561145     History of Changes
Other Study ID Numbers: NL 17278.081.07
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: March 20, 2012
Results First Posted: March 11, 2016
Last Update Posted: March 11, 2016
Last Verified: February 2016

Keywords provided by Lisette de Groot, Wageningen University:
Anorexia of ageing
Anorexia of aging
Energy balance
Elderly

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms