The Body's Response to Food Intake in Older Adults

September 23, 2013 updated by: Wayne Campbell, Purdue University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will maintain current physical activity and take a fluid supplement.
Dietary supplement: 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
Experimental: 2
Participants will maintain current physical activity and take a solid supplement.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in untrained older men and women
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and post-prandial energy expenditure to the differential appetitive responses to fluid versus solid foods in untrained older men and women
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0-0509003024
  • NIH R01 AG021911-0102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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