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

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ClinicalTrials.gov Identifier: NCT00561145
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
Dutch Dairy Organization (NZO)
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University

Brief Summary:

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 or disease Intervention/treatment Phase
Anorexia of Ageing Other: Energy restriction period Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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.
Study Start Date : October 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. Appetite/Satiety Hormones and Questionnaires [ Time Frame: Before and after the energy restriction period. ]
  2. Gastrointestinal Function [ Time Frame: Before and after the energy restriction period ]
  3. Resting Energy Expenditure, Body Composition and Body Weight [ Time Frame: Before and after the energy restriction period ]
  4. Expression of Genes Involved in Energy Metabolism [ Time Frame: Before and after the energy restriction period. ]


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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

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

Publications of Results:
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 Posted: November 20, 2007    Key Record Dates
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