ObesityNCT00260130
Food Rheology and Feeding in Lean and Obese Humans
A study testing food in fluid form and food in solid form in people with Obesity and Overweight, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Diabetes
- What is being tested?
- food in fluid form and food in solid form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-23 or 27-35
- weight stable
- constant habitual activity pattern
- low fruit/vegetable consumer
- non-restrained eater
Who cannot join
- diabetic
- taking medication known to influence appetite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Overweight, Diabetes
- Being tested
- food in fluid form, food in solid form
- Keywords
- obesity, food intake, human, energy balance, beverage
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food in fluid formOther
dietary intake of fluid forms of vegetables
food in solid formOther
dietary intake of solid forms of vegetables
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Consuming fruit and vegetable juice Receives: Other: food in fluid form |
| 2 | Active comparator | Consuming whole fruits and vegetables Receives: Other: food in solid form |
What is being measured
The primary outcome is the main question the study is designed to answer.
satiation and satiety on liquid verses solid foods with concurrent measurements of appetite, dietary intake, energy expenditure and body weight/composition.
Measured: 8 weeks
Secondary outcomes (1)
cephalic phase testing at week 8
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, MPH, PhD, RD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260130
- Sponsor's protocol ID
- DK63185 (completed)
- Other IDs
- R01DK063185, Study 1: 503001275, Study 2: 508002908, Study 3: 505002589
- Status last verified
- May 2013
- First submitted
- 29 Nov 2005
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 1: Viscosity Study Study 2: Meal Timing Study Study 3:Chronic Fluid and Solid Food Intake in Lean and Overweight Individuals
- ClinicalTrials.gov ID
- NCT00260130
- Acronym / sponsor ID
- DK63185 (completed)
- Conditions
- Obesity, Overweight, Diabetes
- Keywords
- obesity, food intake, human, energy balance, beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: food in fluid formConsuming fruit and vegetable juice |
| 2 | Active comparator | Other: food in solid formConsuming whole fruits and vegetables |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 18-23 or 27-35
- weight stable
- constant habitual activity pattern
- low fruit/vegetable consumer
- non-restrained eater
Key exclusion criteria (2 listed)
- diabetic
- taking medication known to influence appetite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food in fluid formdietary intake of fluid forms of vegetables | Other | 1 |
| food in solid formdietary intake of solid forms of vegetables | Other | 2 |
Primary outcome
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
1 secondary outcome
cephalic phase testing at week 8
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Dr. Mattes Laboratory for Sensory and Ingestive Studies web site.Link provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Mattes, MPH, PhD, RD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food in fluid form and food in solid form in people with Obesity and Overweight, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.