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

Primary Purpose

Anorexia of Ageing

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Energy restriction period
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia of Ageing focused on measuring Anorexia of ageing, Anorexia of aging, Energy balance, Elderly

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wageningen University, Division of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Young men

Elderly men

Arm Description

Energy restriction period

Energy restriction period

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Appetite/Satiety Hormones and Questionnaires
Gastrointestinal Function
Resting Energy Expenditure, Body Composition and Body Weight
Expression of Genes Involved in Energy Metabolism

Full Information

First Posted
November 19, 2007
Last Updated
February 12, 2016
Sponsor
Wageningen University
Collaborators
Dutch Dairy Organization (NZO)
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1. Study Identification

Unique Protocol Identification Number
NCT00561145
Brief Title
Impaired Regulation of Energy Balance in Elderly People (Balance Study)
Acronym
Balance
Official Title
Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University
Collaborators
Dutch Dairy Organization (NZO)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia of Ageing
Keywords
Anorexia of ageing, Anorexia of aging, Energy balance, Elderly

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young men
Arm Type
Experimental
Arm Description
Energy restriction period
Arm Title
Elderly men
Arm Type
Experimental
Arm Description
Energy restriction period
Intervention Type
Other
Intervention Name(s)
Energy restriction period
Intervention Description
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 Outcome Measure Information:
Title
Energy Intake Compensation
Description
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)
Time Frame
Average intake of energy during ad lib phase (9 days)
Secondary Outcome Measure Information:
Title
Appetite/Satiety Hormones and Questionnaires
Time Frame
Before and after the energy restriction period.
Title
Gastrointestinal Function
Time Frame
Before and after the energy restriction period
Title
Resting Energy Expenditure, Body Composition and Body Weight
Time Frame
Before and after the energy restriction period
Title
Expression of Genes Involved in Energy Metabolism
Time Frame
Before and after the energy restriction period.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette de Groot, Prof, PhD
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University, Division of Human Nutrition
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6703 HD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21527169
Citation
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.
Results Reference
result
PubMed Identifier
27551314
Citation
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.
Results Reference
derived

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

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