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| Name | Class |
|---|---|
| Dutch Dairy Organization (NZO) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young men | Experimental | Energy restriction period |
|
| Elderly men | Experimental | Energy restriction period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy restriction period | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite/Satiety Hormones and Questionnaires | Before and after the energy restriction period. | |
| Gastrointestinal Function | Before and after the energy restriction period | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisette de Groot, Prof, PhD | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University, Division of Human Nutrition | Wageningen | Gelderland | 6703 HD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21527169 | Result | 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. | |
| 27551314 | Derived | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Men | Young men: 20-40 years of age |
| BG001 | Elderly Men | Elderly men: 65-85 years of age |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | completed (see publication) | Posted | Mean | Standard Deviation | MJ/day | Average intake of energy during ad lib phase (9 days) |
|
Adverse event data were collected during the period of the intervention (from enrollment until the end of the ad libitum phase).
We collected data on adverse events (any undesirable experience occurring to a subject during the study). All adverse events reported spontaneously by the subject or observed by the investigator were recorded.
Serious adverse events were life-threatening events. The chance of those events were considered to be very very low.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Men | Young men: 20-40 years of age |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lisette de Groot | Wageningen University | +31-317482220 | lisette.degroot@wur.nl |
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| 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Appetite/Satiety Hormones and Questionnaires | Not Posted | Before and after the energy restriction period. |
| Secondary | Gastrointestinal Function | Not Posted | Before and after the energy restriction period |
| Secondary | Resting Energy Expenditure, Body Composition and Body Weight | Not Posted | Before and after the energy restriction period |
| Secondary | Expression of Genes Involved in Energy Metabolism | Not Posted | Before and after the energy restriction period. |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Elderly Men | Elderly men: 65-85 years of age | 0 | 17 | 0 | 17 |
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