NCT00798408

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
Last Updated

September 24, 2013

Status Verified

December 1, 2009

Enrollment Period

1.7 years

First QC Date

November 25, 2008

Last Update Submit

September 23, 2013

Conditions

Elderly

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Fluid Supplement

2

EXPERIMENTAL

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

Dietary Supplement: Solid Supplement

Interventions

Fluid SupplementDIETARY_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

1
Solid SupplementDIETARY_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

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Foods and Nutrition

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 26, 2008

Study Start

February 1, 2006

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

September 24, 2013

Record last verified: 2009-12

Locations

US(1)