Trial Outcomes & Findings for Impaired Regulation of Energy Balance in Elderly People (Balance Study) (NCT NCT00561145)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

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

Results posted on

2016-03-11

Participant Flow

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

Participant milestones

Participant milestones
Measure	Young Men Young men should be 20-40 years of age. Men will be excluded based on the following exclusion criteria: body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome.	Elderly Men Elderly men should be 65-85 years of age. Men will be excluded based on the following exclusion criteria: body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome.
Overall Study STARTED	15	17
Overall Study COMPLETED	15	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Young Men n=15 Participants Young men: 20-40 years of age	Elderly Men n=17 Participants Elderly men: 65-85 years of age	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	24 years INTER_QUARTILE_RANGE 1 • n=5 Participants	68 years INTER_QUARTILE_RANGE 1 • n=7 Participants	50 years INTER_QUARTILE_RANGE 1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Netherlands	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

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

Population: completed (see publication)

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)

Outcome measures

Outcome measures
Measure	Young Men n=15 Participants Young men: 20-40 years of age	Elderly Men n=17 Participants Elderly men: 65-85 years of age
Energy Intake Compensation	1 MJ/day Standard Deviation 1	1 MJ/day Standard Deviation 1

SECONDARY outcome

Timeframe: Before and after the energy restriction period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after the energy restriction period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after the energy restriction period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after the energy restriction period.

Outcome measures

Outcome data not reported

Adverse Events

Young Men

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Elderly Men

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Lisette de Groot

Wageningen University

Phone: +31-317482220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place