NCT00798668

Brief Summary

The purpose of this research study is to determine the effects of food supplements and strength training on appetite, the amount of energy expended, and body composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

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

September 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
7 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

March 1, 2010

Enrollment Period

11 months

First QC Date

November 25, 2008

Last Update Submit

September 23, 2013

Conditions

Keywords

Endocrine and Gastrointestinal Response to Food

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 trained and untrained, elderly people.

    6 weeks

Secondary Outcomes (1)

  • Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and gastrointestinal transit time, to the differential appetitive responses to fluid versus solid foods in trained and untrained, elderly people

    6 weeks

Study Arms (4)

1

EXPERIMENTAL

participants continue current exercise and take liquid supplement

Dietary Supplement: Liquid Supplements

2

EXPERIMENTAL

Participants continue current exercise and take solid supplement

Dietary Supplement: Solid Supplement

3

EXPERIMENTAL

Participants continue current sedentary behavior and take liquid supplements

Dietary Supplement: Liquid Supplements

4

EXPERIMENTAL

Participants continue current sedentary behavior and take solid supplements

Dietary Supplement: Solid Supplement

Interventions

Liquid SupplementsDIETARY_SUPPLEMENT

Liquid supplement that provides 12.5% of the subjects total energy requirement.

13
Solid SupplementDIETARY_SUPPLEMENT

Solid supplement that provides 12.5% of the subjects total energy requirement.

24

Eligibility Criteria

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

You may qualify if:

  • All subjects must meet the following eligibility 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
  • Confirmation of acceptability of eating the study test foods (solids and fluids)
  • Trained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
  • Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
  • Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)
  • Sedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
  • Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)
  • +1 more criteria

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
  • Study foods are found to be unacceptable for consumption by the subject
  • Clinically diagnosed osteoporosis
  • Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
  • Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)
  • Performed 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
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

September 1, 2006

Primary Completion

August 1, 2007

Study Completion

May 1, 2008

Last Updated

September 24, 2013

Record last verified: 2010-03

Locations