NCT00260130

Brief Summary

The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The marked recent increase in overweight and obesity prevalence implicates behavioral factors in the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in part, to increasing consumption of energy-yeilding beverages since they are a significant and increasing source of dietarty energy and they elicit weaker appetitive and dietary responses than solid foods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable obesity

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

February 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

2.8 years

First QC Date

November 29, 2005

Last Update Submit

May 28, 2013

Conditions

ObesityOverweightDiabetes

Keywords

obesityfood intakehumanenergy balancebeverage

Outcome Measures

Primary Outcomes (1)

  • satiation and satiety on liquid verses solid foods with concurrent measurements of appetite, dietary intake, energy expenditure and body weight/composition.

    8 weeks

Secondary Outcomes (1)

  • cephalic phase testing at week 8

    30 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

Consuming fruit and vegetable juice

Other: food in fluid form

2

ACTIVE COMPARATOR

Consuming whole fruits and vegetables

Other: food in solid form

Interventions

food in fluid formOTHER

dietary intake of fluid forms of vegetables

1
food in solid formOTHER

dietary intake of solid forms of vegetables

2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-23 or 27-35
  • weight stable
  • constant habitual activity pattern
  • low fruit/vegetable consumer
  • non-restrained eater

You may not qualify if:

  • diabetic
  • taking medication known to influence appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus

Interventions

Food

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Richard D Mattes, MPH, PhD, RD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

February 1, 2005

Primary Completion

December 1, 2007

Study Completion

July 1, 2009

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)