The Body's Response to Food Intake in Trained, Older Adults
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of this research study is to determine the effects of food supplements and strength training on appetite, the amount of energy expended, and body composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedSeptember 24, 2013
March 1, 2010
11 months
November 25, 2008
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in trained and untrained, elderly people.
6 weeks
Secondary Outcomes (1)
Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and gastrointestinal transit time, to the differential appetitive responses to fluid versus solid foods in trained and untrained, elderly people
6 weeks
Study Arms (4)
1
EXPERIMENTALparticipants continue current exercise and take liquid supplement
2
EXPERIMENTALParticipants continue current exercise and take solid supplement
3
EXPERIMENTALParticipants continue current sedentary behavior and take liquid supplements
4
EXPERIMENTALParticipants continue current sedentary behavior and take solid supplements
Interventions
Liquid supplement that provides 12.5% of the subjects total energy requirement.
Solid supplement that provides 12.5% of the subjects total energy requirement.
Eligibility Criteria
You may qualify if:
- All subjects must meet the following eligibility 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
- Confirmation of acceptability of eating the study test foods (solids and fluids)
- Trained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
- Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
- Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)
- Sedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
- Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)
- +1 more criteria
You may not qualify if:
- 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
- Clinically diagnosed as diabetic
- Study foods are found to be unacceptable for consumption by the subject
- Clinically diagnosed osteoporosis
- Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
- Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)
- Performed 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Foods and Nutrition
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
September 1, 2006
Primary Completion
August 1, 2007
Study Completion
May 1, 2008
Last Updated
September 24, 2013
Record last verified: 2010-03