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

Anorexia of Ageing Clinical Trial

— Balance  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561145
• Other study ID #: NL 17278.081.07
• Status: Completed
• Phase: N/A
• First received: November 19, 2007
• Last updated: February 12, 2016
• Start date: October 2007
• Est. completion date: March 2012

Study information

• Verified date: February 2016
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anorexia
• Anorexia of Ageing

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Dutch Dairy Organization (NZO)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Winkels RM, Jolink-Stoppelenburg A, de Graaf K, Siebelink E, Mars M, de Groot L. Energy intake compensation after 3 weeks of restricted energy intake in young and elderly men. J Am Med Dir Assoc. 2011 May;12(4):277-86. doi: 10.1016/j.jamda.2010.08.011. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy Intake Compensation	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)	Average intake of energy during ad lib phase (9 days)	No
Secondary	Appetite/Satiety Hormones and Questionnaires		Before and after the energy restriction period.	No
Secondary	Gastrointestinal Function		Before and after the energy restriction period	No
Secondary	Resting Energy Expenditure, Body Composition and Body Weight		Before and after the energy restriction period	No
Secondary	Expression of Genes Involved in Energy Metabolism		Before and after the energy restriction period.	No