Overview

This trial is active, not recruiting.

Condition anorexia of ageing
Treatment energy restriction period
Sponsor Wageningen University
Collaborator Dutch Dairy Organization (NZO)
Start date October 2007
End date March 2008
Trial size 30 participants
Trial identifier NCT00561145, NL 17278.081.07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Young men: 20-40 years of age
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: 65-85 years of age
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.

Primary Outcomes

Measure
Energy intake compensation
time frame: Daily

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male participants from 20 years up to 85 years old.

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

Additional Information

Official title Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.
Principal investigator Lisette de Groot, Prof, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Wageningen University.