The Body's Response to Food Intake in Trained, Older Adults

Purdue University

Status: Completed

Conditions: Elderly

Treatments: Dietary Supplement: Liquid Supplements; Dietary Supplement: Solid Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00798668

0607004184

NIH R01 AG021911-0102

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

1

Experimental group

Description:

participants continue current exercise and take liquid supplement

Treatment:

Dietary Supplement: Liquid Supplements

2

Experimental group

Description:

Participants continue current exercise and take solid supplement

Treatment:

Dietary Supplement: Solid Supplement

3

Experimental group

Description:

Participants continue current sedentary behavior and take liquid supplements

Treatment:

Dietary Supplement: Liquid Supplements

4

Experimental group

Description:

Participants continue current sedentary behavior and take solid supplements

Treatment:

Dietary Supplement: Solid Supplement