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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Wageningen University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Dutch Dairy Organization (NZO)
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00561145
First received: November 19, 2007
Last updated: January 16, 2008
Last verified: January 2008
  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: Daily ]

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. ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: Young men
Young men: 20-40 years of age
Other: Energy restriction period
The experiment can be divided in 3 phases, namely (1) run-in period, (2) energy restriction period and (3) ad libitum food intake period.
Experimental: Elderly men
Elderly men: 65-85 years of age
Other: Energy restriction period
The experiment can be divided in 3 phases, namely (1) run-in period, (2) energy restriction period and (3) ad libitum food intake period.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
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
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: 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

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00561145     History of Changes
Other Study ID Numbers: NL 17278.081.07
Study First Received: November 19, 2007
Last Updated: January 16, 2008
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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014