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

Elderly Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798668
• Other study ID #: 0607004184
• Secondary ID: NIH R01 AG021911
• Status: Completed
• Phase: N/A
• First received: November 25, 2008
• Last updated: September 23, 2013
• Start date: September 2006
• Est. completion date: May 2008

Study information

• Verified date: March 2010
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elderly

Intervention

Dietary Supplement:
• Liquid Supplements
Liquid supplement that provides 12.5% of the subjects total energy requirement.
• Solid Supplement
Solid supplement that provides 12.5% of the subjects total energy requirement.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes