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The Body's Response to Food Intake in Older Adults

This study has been completed.
Sponsor:
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT00798408
First received: November 25, 2008
Last updated: December 16, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Elderly
 Dietary Supplement: Fluid Supplement
Dietary Supplement: Solid Supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

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 untrained older men and women [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: February 2006
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798408

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier: NCT00798408     History of Changes
Other Study ID Numbers: 0-0509003024, NIH R01 AG021911-0102
Study First Received: November 25, 2008
Last Updated: December 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Evaluate the effects of energy-yielding fluids and solids endocrine and metabolic response to food in the elderly

ClinicalTrials.gov processed this record on May 23, 2013