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Completed

NCT Number: NCT00561145

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

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.

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Key information

Conditions

Anorexia of Ageing

Age range

20 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6703 HD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energy restriction period

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Dutch Dairy Organization (NZO)

Registry information

Official study title

Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.

Acronym: Balance

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Nov 20, 2007
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.