The Body's Response to Food Intake in Older Adults

Elderly Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798408
• Other study ID #: 0-0509003024
• Secondary ID: NIH R01 AG021911
• Status: Completed
• Phase: N/A
• First received: November 25, 2008
• Last updated: September 23, 2013
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: December 2009
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Elderly

Intervention

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
• 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

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 untrained older men and women		3 weeks	Yes
Secondary	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		3 weeks	Yes