Clinical trial NCT00798408: The Body's Response to Food Intake in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Evaluate the effects of energy-yielding fluids and solids endocrine and metabolic response to food in the elderly
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: We propose to critically evaluate the effects of energy-yielding fluids and solids on acute appetite variables, daily food intake, and specific endocrine and metabolic response to food in the elderly. The results of these studies will provide further evidence to support that nutrition may provide safe and effective non-pharmacological therapies to counter the compromised regulation of energy balance experienced by many elderly people.


Eligibility criteria: Inclusion Criteria:

* Age range: 60 years and older
* Body mass index between 20-29 kg/m2
* Weight stable (\< 2 kg weight change within last 6 months)
* Non-smoking
* Constant habitual activity patterns within last 3 months
* Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose \<110 mg/dl)
* Not taking medications known to influence appetite or metabolism
* Non-diabetic
* Resistive exercise training (≤2 times a week) based on reported physical activity levels (questionnaire)
* Active fitness level (≤3, 30-minute aerobic exercise sessions/week)
* Confirmation of acceptability of eating the study test foods (solids and fluids)

Exclusion Criteria:

* Age: \<60 years
* Body mass index: outside of the 20-29 kg/m2 range
* Gained or lost \> 4.5 kg within the last 6 months
* Smoker (currently or within the last year)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
* Clinically diagnosed as diabetic
* Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Perform ≥ 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels (questionnaire)
* Study foods are found to be unacceptable for consumption by the subject

Primary outcomes:
measure: Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in untrained older men and women
timeFrame: 3 weeks
Secondary outcomes:
measure: Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and post-prandial energy expenditure to the differential appetitive responses to fluid versus solid foods in untrained older men and women
timeFrame: 3 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: