- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260130
Food Rheology and Feeding in Lean and Obese Humans
May 28, 2013 updated by: Richard Mattes, Purdue University
Study 1: Viscosity Study Study 2: Meal Timing Study Study 3:Chronic Fluid and Solid Food Intake in Lean and Overweight Individuals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Three human studies are propsed to more fully characterized attributes of liquids and solids that may account for the differential appetitive responses they elicit, potential contributory mechanisms as well as the dietary implications of their consumption.
Study 1 will contrast the acute effects of fluid and solid foods varying in macronutrient content on satiation, satiety and feeding.
Study 2 will determine if the pattern of fluid and solid ingestion influences satiety and feeding by monitoring appetitive and dietary responses to energy and macronutrient matched fluid and solid loads ingested as meal components or between meal snacks.
To better assess the clinical implications ofdiets incorpprating liquid or solid supplements.
Study 3 will entail chronic ingestion of matched energy yeilding fluid or solid loads with concurrent measurement of appetite, dietary intake, energy expenditureand body weight/composition.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47906
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 18-23 or 27-35
- weight stable
- constant habitual activity pattern
- low fruit/vegetable consumer
- non-restrained eater
Exclusion Criteria:
- diabetic
- taking medication known to influence appetite
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Consuming fruit and vegetable juice
|
dietary intake of fluid forms of vegetables
|
|
Active Comparator: 2
Consuming whole fruits and vegetables
|
dietary intake of solid forms of vegetables
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
satiation and satiety on liquid verses solid foods with concurrent measurements of appetite, dietary intake, energy expenditure and body weight/composition.
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
cephalic phase testing at week 8
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard D Mattes, MPH, PhD, RD, Purdue University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
November 29, 2005
First Submitted That Met QC Criteria
November 29, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
May 30, 2013
Last Update Submitted That Met QC Criteria
May 28, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK63185 (completed)
- R01DK063185 (U.S. NIH Grant/Contract)
- Study 1: 503001275
- Study 2: 508002908
- Study 3: 505002589
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.