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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00561145
Acronym
Balance
Enrollment
32
Registered
2007-11-20
Start date
2007-10-31
Completion date
2012-03-31
Last updated
2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia of Ageing

Keywords

Anorexia of ageing, Anorexia of aging, Energy balance, Elderly

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.

Interventions

OTHEREnergy 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.

Sponsors

Dutch Dairy Organization (NZO)
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Energy Intake CompensationAverage 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)

Secondary

MeasureTime frame
Appetite/Satiety Hormones and QuestionnairesBefore and after the energy restriction period.
Gastrointestinal FunctionBefore and after the energy restriction period
Resting Energy Expenditure, Body Composition and Body WeightBefore and after the energy restriction period
Expression of Genes Involved in Energy MetabolismBefore and after the energy restriction period.

Countries

Netherlands

Participant flow

Recruitment details

Subjects will be recruited by publishing advertisements in local newspapers and by sending out general e-mails to an e-mail list of persons who had indicated their interest in participating in studies of our university

Participants by arm

ArmCount
Young Men
Young men: 20-40 years of age
15
Elderly Men
Elderly men: 65-85 years of age
17
Total32

Baseline characteristics

CharacteristicElderly MenYoung MenTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
17 Participants0 Participants17 Participants
Age, Categorical
Between 18 and 65 years
0 Participants15 Participants15 Participants
Age, Continuous68 years
INTER_QUARTILE_RANGE 1
24 years
INTER_QUARTILE_RANGE 1
50 years
INTER_QUARTILE_RANGE 1
Region of Enrollment
Netherlands
17 participants15 participants32 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
17 Participants15 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 150 / 17
serious
Total, serious adverse events
0 / 150 / 17

Outcome results

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)

Time frame: Average intake of energy during ad lib phase (9 days)

Population: completed (see publication)

ArmMeasureValue (MEAN)Dispersion
Young MenEnergy Intake Compensation1 MJ/dayStandard Deviation 1
Elderly MenEnergy Intake Compensation1 MJ/dayStandard Deviation 1
Secondary

Appetite/Satiety Hormones and Questionnaires

Time frame: Before and after the energy restriction period.

Secondary

Expression of Genes Involved in Energy Metabolism

Time frame: Before and after the energy restriction period.

Secondary

Gastrointestinal Function

Time frame: Before and after the energy restriction period

Secondary

Resting Energy Expenditure, Body Composition and Body Weight

Time frame: Before and after the energy restriction period

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026