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

This study has been completed.
Sponsor:
Collaborator:
Dutch Dairy Organization (NZO)
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier:
NCT00561145
First received: November 19, 2007
Last updated: February 12, 2016
Last verified: February 2016
  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: 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 Wageningen University:

Primary Outcome Measures:
  • Energy Intake Compensation [ Time Frame: Average intake of energy during ad lib phase (9 days) ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
  • Gastrointestinal Function [ Time Frame: Before and after the energy restriction period ] [ Designated as safety issue: No ]
  • Resting Energy Expenditure, Body Composition and Body Weight [ Time Frame: Before and after the energy restriction period ] [ Designated as safety issue: No ]
  • Expression of Genes Involved in Energy Metabolism [ Time Frame: Before and after the energy restriction period. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Lisette de Groot, Professor, Wageningen University
ClinicalTrials.gov Identifier: NCT00561145     History of Changes
Other Study ID Numbers: NL 17278.081.07 
Study First Received: November 19, 2007
Results First Received: March 20, 2012
Last Updated: February 12, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
Anorexia of ageing
Anorexia of aging
Energy balance
Elderly

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

ClinicalTrials.gov processed this record on July 24, 2016