Oral Intake ReducedEatSpeedNCT01684553
The Effect of Changing the Eating Speed on Energy Intake
A study testing Slow eating condition and Fast eating condition in people with Oral Intake Reduced, run by Texas Christian University at 1 site in United States.
Trial summary
It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and lesser feelings of hunger and desire to eat and higher levels of fullness after the meal compared to eating the same meal more quickly. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Intake Reduced
- What is being tested?
- Slow eating condition and Fast eating condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2011
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 19-65 years.
Who cannot join
- Severe obesity (BMI ≥ 40 kg/m2),
- dieting,
- taking medications that affect appetite,
- participating in > 150 min/wk of vigorous physical activity,
- smoking,
- drinking heavily (men: > 14 alcoholic drinks/wk; women: > 7 alcoholic drinks/wk),
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- self-reported disordered eating,
- depression,
- type 1 or 2 diabetes,
- adrenal disease, or
- untreated thyroid disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Changing the Eating Speed on Energy Intake: a Randomized Cross-over Study
It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and lesser feelings of hunger and desire to eat and higher levels of fullness after the meal compared to eating the same meal more quickly.
- Conditions
- Oral Intake Reduced
- Being tested
- Slow eating condition, Fast eating condition
- Keywords
- Eating speed, energy intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow eating conditionBehavioural
The subjects were asked to eat their meal slowly during the slow eating condition
Fast eating conditionBehavioural
The subjects were asked to eat their meal quickly during the fast eating condition
| Study group | Role | What they receive |
|---|---|---|
| Slow eating condition | Experimental | The subjects were asked to eat their meal slowly during the slow eating condition Receives: Behavioral: Slow eating condition |
| Fast eating condition | Active comparator | The subjects were asked to eat their meal quickly during the fast eating condition Receives: Behavioral: Fast eating condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal energy intake
Measured: Day 1
Meal energy intake
Measured: Day 2
Secondary outcomes (4)
Hunger questionnaire
Measured: 0 and 60 min after the meal began
Fullness questionnaire
Measured: 0 and 60 min after the meal began
Desire to eat questionnaire
Measured: 0 and 60 min after the meal began
Thirst questionnaire
Measured: 0 and 60 min after the meal began
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Intake ReducedStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Shah, Texas Christian University
- Investigators
- Meena Shah, Ph.D., Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684553
- Sponsor's protocol ID
- F10-39
- Acronym
- EatSpeed
- Status last verified
- Sep 2012
- First submitted
- 5 Sep 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changing the Eating Speed on Energy Intake: a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT01684553
- Acronym / sponsor ID
- EatSpeed / F10-39
- Conditions
- Oral Intake Reduced
- Keywords
- Eating speed, energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Sep 2012 (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.
It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and lesser feelings of hunger and desire to eat and higher levels of fullness after the meal compared to eating the same meal more quickly.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow eating condition | Experimental | Behavioral: Slow eating conditionThe subjects were asked to eat their meal slowly during the slow eating condition |
| Fast eating condition | Active comparator | Behavioral: Fast eating conditionThe subjects were asked to eat their meal quickly during the fast eating condition |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women ages 19-65 years.
Key exclusion criteria (11 listed)
- Severe obesity (BMI ≥ 40 kg/m2),
- dieting,
- taking medications that affect appetite,
- participating in > 150 min/wk of vigorous physical activity,
- smoking,
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 |
|---|---|---|
| Slow eating conditionThe subjects were asked to eat their meal slowly during the slow eating condition | Behavioural | Slow eating condition |
| Fast eating conditionThe subjects were asked to eat their meal quickly during the fast eating condition | Behavioural | Fast eating condition |
Primary outcome
Meal energy intake
Time frame: Day 1
Meal energy intake
Time frame: Day 2
4 secondary outcomes
Hunger questionnaire
Time frame: 0 and 60 min after the meal began
Fullness questionnaire
Time frame: 0 and 60 min after the meal began
Desire to eat questionnaire
Time frame: 0 and 60 min after the meal began
Thirst questionnaire
Time frame: 0 and 60 min after the meal began
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 13 Sep 2012.
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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.
Meena Shah, Ph.D. principal investigator
Tzu Chi 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 Slow eating condition and Fast eating condition in people with Oral Intake Reduced, run by Texas Christian 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 1 inclusion and 11 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 13 Sep 2012. 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?
Meal energy intake (time frame: Day 1). The study lists 2 primary outcomes in all. 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 13 Sep 2012.