NCT00761553

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

September 25, 2008

Last Update Submit

January 16, 2013

Conditions

Keywords

The study is designed to determine the effects of food supplements and strength training.

Outcome Measures

Primary Outcomes (1)

  • Appetite questionnaire, urine collection, strength testing, body composition, resting metabolic rate, food records, breath sample, activity assessments, dietary supplements, nightly logs, and resistive exercise.

    23 weeks

Study Arms (4)

1

EXPERIMENTAL

Solid dietary supplements with exercise

Other: Dietary supplements with exercise

2

EXPERIMENTAL

Solid dietary supplements without exercise

Dietary Supplement: Dietary supplement without exercise

3

EXPERIMENTAL

Liquid dietary supplements with exercise

Other: Dietary supplements with exercise

4

EXPERIMENTAL

Liquid supplements without exercise

Dietary Supplement: Dietary supplement without exercise

Interventions

Resistive exercise along with consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.

13

Consuming two dietary supplements every day during both 8 week intervention periods, for a total of 16 weeks.

24

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 55 and older
  • Body mass index 20 to ≤35 kg/m2
  • Weight stable (\<4kg change within the last 3 months)
  • Constant habitual activity patterns (no deviation \> 1x/wk of 30 min/session within last 3 months)
  • Clinically normal blood and urine profiles as determined by our study physician
  • Not taking medications known to influence appetite nor any anti-inflammatory steroid medications
  • No hip replacements

You may not qualify if:

  • Adults with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Dietary SupplementsExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Wayne Campbell, Ph.D.

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2009

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations