NCT00561145

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4 years until next milestone

Results Posted

Study results publicly available

March 11, 2016

Completed
Last Updated

March 11, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

November 19, 2007

Results QC Date

March 20, 2012

Last Update Submit

February 12, 2016

Conditions

Anorexia of Ageing

Keywords

Anorexia of ageingAnorexia of agingEnergy balanceElderly

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Appetite/Satiety Hormones and Questionnaires

    Before and after the energy restriction period.

  • Gastrointestinal Function

    Before and after the energy restriction period

  • Resting Energy Expenditure, Body Composition and Body Weight

    Before and after the energy restriction period

  • Expression of Genes Involved in Energy Metabolism

    Before and after the energy restriction period.

Study Arms (2)

Young men

EXPERIMENTAL

Energy restriction period

Other: Energy restriction period

Elderly men

EXPERIMENTAL

Energy restriction period

Other: Energy restriction period

Interventions

Energy restriction periodOTHER

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.

Elderly menYoung men

Eligibility Criteria

Age20 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men
  • healthy
  • and 65-85 years of age
  • normal weight
  • free-living in Wageningen and surrounding

You may not qualify if:

  • anemia
  • diabetes
  • restrained eating
  • dementia
  • weight changes of \> 2 kg during the last 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6703 HD, Netherlands

Location

Related Publications (2)

  • 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. Epub 2010 Oct 20.

    PMID: 21527169RESULT

  • Van Bussel IP, Jolink-Stoppelenburg A, De Groot CP, Muller MR, Afman LA. Differences in genome-wide gene expression response in peripheral blood mononuclear cells between young and old men upon caloric restriction. Genes Nutr. 2016 May 6;11:13. doi: 10.1186/s12263-016-0528-0. eCollection 2016.

    PMID: 27551314DERIVED

Results Point of Contact

Title
Dr Lisette de Groot
Organization
Wageningen University
lisette.degroot@wur.nl
+31-317482220

Study Officials

  • Lisette de Groot, Prof, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2012

Last Updated

March 11, 2016

Results First Posted

March 11, 2016

Record last verified: 2016-02

Locations

NL(1)