The Body's Response to Food Intake in Trained, Older Adults - Full Text View

Sponsored by:	Purdue University
Information provided by:	Purdue University
ClinicalTrials.gov Identifier:	NCT00798668

Purpose

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.

Condition	Intervention
Elderly	Dietary Supplement: Liquid Supplements Dietary Supplement: Solid Supplement

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:

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. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	September 2006
Study Completion Date:	May 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental participants continue current exercise and take liquid supplement	Dietary Supplement: Liquid Supplements Liquid supplement that provides 12.5% of the subjects total energy requirement.
2: Experimental Participants continue current exercise and take solid supplement	Dietary Supplement: Solid Supplement Solid supplement that provides 12.5% of the subjects total energy requirement.
3: Experimental Participants continue current sedentary behavior and take liquid supplements	Dietary Supplement: Liquid Supplements Liquid supplement that provides 12.5% of the subjects total energy requirement.
4: Experimental Participants continue current sedentary behavior and take solid supplements	Dietary Supplement: Solid Supplement Solid supplement that provides 12.5% of the subjects total energy requirement.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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)
Active fitness level (≤ 2, 30-minute aerobic exercise sessions/week)

Exclusion Criteria:

All subjects will be excluded based on the following exclusionary 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
Study foods are found to be unacceptable for consumption by the subject
Clinically diagnosed osteoporosis

Trained subjects will be excluded based on the following exclusionary criteria:

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)

Sedentary subjects will be excluded based on the following exclusionary criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798668

Locations

United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907

Sponsors and Collaborators

Purdue University

More Information

No publications provided

Responsible Party:	Purdue University ( Wayne Campbell )
Study ID Numbers:	0607004184, NIH R01 AG021911-0102
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798668 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Purdue University:

Endocrine and Gastrointestinal Response to Food

ClinicalTrials.gov processed this record on September 10, 2009