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Food Rheology and Feeding in Lean and Obese Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00260130
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : May 30, 2013
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Richard Mattes, Purdue University

Tracking Information
First Submitted Date  ICMJE November 29, 2005
First Posted Date  ICMJE December 1, 2005
Last Update Posted Date May 30, 2013
Study Start Date  ICMJE February 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2005)
satiation and satiety on liquid verses solid foods with concurrent measurements of appetite, dietary intake, energy expenditure and body weight/composition.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
cephalic phase testing at week 8 [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2005)
cephalic phase testing at week 8
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Rheology and Feeding in Lean and Obese Humans
Official Title  ICMJE Study 1: Viscosity Study Study 2: Meal Timing Study Study 3:Chronic Fluid and Solid Food Intake in Lean and Overweight Individuals
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Obesity
  • Overweight
  • Diabetes
Intervention  ICMJE
  • Other: food in fluid form
    dietary intake of fluid forms of vegetables
  • Other: food in solid form
    dietary intake of solid forms of vegetables
Study Arms  ICMJE
  • Active Comparator: 1
    Consuming fruit and vegetable juice
    Intervention: Other: food in fluid form
  • Active Comparator: 2
    Consuming whole fruits and vegetables
    Intervention: Other: food in solid form
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 17, 2007)
34
Original Enrollment  ICMJE
 (submitted: November 29, 2005)
63
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00260130
Other Study ID Numbers  ICMJE DK63185 (completed)
R01DK063185 ( U.S. NIH Grant/Contract )
Study 1: 503001275
Study 2: 508002908
Study 3: 505002589
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Mattes, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Richard D Mattes, MPH, PhD, RD Purdue University
PRS Account Purdue University
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP