AppetiteNCT01406886
Combined Effects of Energy Density and Eating Rate on Appetite
A study testing Eating rate in people with Appetite, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Eating rate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-27 kg/m2
- Weight stable
Who cannot join
- Chronic used of OTC or prescription drugs known to affect metabolism
- Chronic disease
- Gastric bypass surgery
- Disordered eating
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Energy Density and Eating Rate on Energy Intake and Biomarkers of Satiety
This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake.
- Conditions
- Appetite
- Being tested
- Eating rate
- Keywords
- Modifiable environmental, behavioral factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating rateBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Energy density | Experimental | Low or high energy density meal Receives: Behavioral: Eating rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Measured: 1 meal
Secondary outcomes (5)
Subjective appetite
Measured: 0-180 min
Postprandial peptide-YY response
Measured: 0-180 min
Postprandial ghrelin response
Measured: 0-180 min
Postprandial glucagon-like peptide-1 response
Measured: 0-180 min
Postprandial pancreatic polypeptide response
Measured: 0-180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppetiteStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, James Philip Karl, United States Army Research Institute of Environmental Medicine
- Investigators
- Scott J Montain, PhD, Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406886
- Sponsor's protocol ID
- H09-28
- Status last verified
- Oct 2017
- First submitted
- 5 Jul 2011
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Karl JP, Young AJ, Rood JC, Montain SJ. Independent and combined effects of eating rate and energy density on energy intake, appetite, and gut hormones. Obesity (Silver Spring). 2013 Mar;21(3):E244-52. doi: 10.1002/oby.20075.
PubMed 23592679
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Energy Density and Eating Rate on Energy Intake and Biomarkers of Satiety
- ClinicalTrials.gov ID
- NCT01406886
- Acronym / sponsor ID
- H09-28
- Conditions
- Appetite
- Keywords
- Modifiable environmental, behavioral factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Aug 2011 (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.
This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy density | Experimental | Behavioral: Eating rateLow or high energy density meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18-27 kg/m2
- Weight stable
Key exclusion criteria (5 listed)
- Chronic used of OTC or prescription drugs known to affect metabolism
- Chronic disease
- Gastric bypass surgery
- Disordered eating
- Pregnant or breastfeeding
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 |
|---|---|---|
| Eating rate | Behavioural | Energy density |
Primary outcome
Energy intake
Time frame: 1 meal
5 secondary outcomes
Subjective appetite
Time frame: 0-180 min
Postprandial peptide-YY response
Time frame: 0-180 min
Postprandial ghrelin response
Time frame: 0-180 min
Postprandial glucagon-like peptide-1 response
Time frame: 0-180 min
Postprandial pancreatic polypeptide response
Time frame: 0-180 min
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 17 Oct 2017.
- Results publication: PubMed 23592679Karl JP, Young AJ, Rood JC, Montain SJ. Independent and combined effects of eating rate and energy density on energy intake, appetite, and gut hormones. Obesity (Silver Spring). 2013 Mar;21(3):E244-52. doi: 10.1002/oby.20075.
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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.
Scott J Montain, PhD principal investigator
US Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating rate in people with Appetite, run by United States Army Research Institute of Environmental Medicine 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 2 inclusion and 5 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 17 Oct 2017. 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?
Energy intake (time frame: 1 meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406886, which also lists 1 linked publication.
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 17 Oct 2017.