Anorexia of AgeingBalanceNCT00561145
Impaired Regulation of Energy Balance in Elderly People (Balance Study)
A study testing Energy restriction period in people with Anorexia of Ageing, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia of Ageing
- What is being tested?
- Energy restriction period
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men
- healthy
- 20-40 and 65-85 years of age
- normal weight
- free-living in Wageningen and surrounding
Who cannot join
- anemia
- diabetes
- restrained eating
- dementia
- weight changes of > 2 kg during the last 2 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6703 HD
About this study
Official title: Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.
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.
- Conditions
- Anorexia of Ageing
- Being tested
- Energy restriction period
- Keywords
- Anorexia of ageing, Anorexia of aging, Energy balance, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Young men | Experimental | Energy restriction period Receives: Other: Energy restriction period |
| Elderly men | Experimental | Energy restriction period Receives: Other: Energy restriction period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Average intake of energy during ad lib phase (9 days)
Secondary outcomes (4)
Appetite/Satiety Hormones and Questionnaires
Measured: Before and after the energy restriction period.
Gastrointestinal Function
Measured: Before and after the energy restriction period
Resting Energy Expenditure, Body Composition and Body Weight
Measured: Before and after the energy restriction period
Expression of Genes Involved in Energy Metabolism
Measured: Before and after the energy restriction period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia of AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Dairy Organization (NZO)
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Lisette de Groot, Prof, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561145
- Sponsor's protocol ID
- NL 17278.081.07
- Acronym
- Balance
- Status last verified
- Feb 2016
- First submitted
- 19 Nov 2007
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21527169Van 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.
PubMed 27551314
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Regulation of Energy Balance in Elderly People and the Underlying Physiological Mechanisms.
- ClinicalTrials.gov ID
- NCT00561145
- Acronym / sponsor ID
- Balance / NL 17278.081.07
- Conditions
- Anorexia of Ageing
- Keywords
- Anorexia of ageing, Anorexia of aging, Energy balance, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Dutch Dairy Organization (NZO)
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Posted 11 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young men | Experimental | Other: Energy restriction periodEnergy restriction period |
| Elderly men | Experimental | Other: Energy restriction periodEnergy restriction period |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- men
- healthy
- 20-40 and 65-85 years of age
- normal weight
- free-living in Wageningen and surrounding
Key exclusion criteria (5 listed)
- anemia
- diabetes
- restrained eating
- dementia
- weight changes of > 2 kg during the last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy restriction periodThe 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. | Other | Elderly men, Young men |
Primary outcome
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)
4 secondary outcomes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21527169Winkels 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.
- Derived from this study: PubMed 27551314Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisette de Groot, Prof, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy restriction period in people with Anorexia of Ageing, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Intake Compensation (time frame: Average intake of energy during ad lib phase (9 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00561145, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.