The Body's Response to Food Intake in Older Adults

NCT ID: NCT00798408

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elderly

Keywords

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Evaluate the effects of energy-yielding fluids and solids endocrine and metabolic response to food in the elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Participants will maintain current physical activity and take a fluid supplement.

Group Type EXPERIMENTAL

Fluid Supplement

Intervention Type DIETARY_SUPPLEMENT

The fluid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation\*1.5 activity factor, volume, and amount and type of macronutrients

2

Participants will maintain current physical activity and take a solid supplement.

Group Type EXPERIMENTAL

Solid Supplement

Intervention Type DIETARY_SUPPLEMENT

The solid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation\*1.5 activity factor, volume, and amount and type of macronutrients

Interventions

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Fluid Supplement

The fluid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation\*1.5 activity factor, volume, and amount and type of macronutrients

Intervention Type DIETARY_SUPPLEMENT

Solid Supplement

The solid food items will contain 25% of each individual's total energy intake estimated from the gender-specific Harris Benedict equation\*1.5 activity factor, volume, and amount and type of macronutrients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Wayne Campbell

Professor, Foods and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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NIH R01 AG021911-0102

Identifier Type: -

Identifier Source: secondary_id

0-0509003024

Identifier Type: -

Identifier Source: org_study_id