Food ConsumptionNCT01758302
A Pilot Laboratory Study Investigating How Physical Tasks and Hunger Affect Taste Perception
A study testing Simple physical task, Complex physical task and Cookies in people with Food Consumption and Perseverance, run by The Miriam Hospital at 1 site in United States.
Trial summary
This one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Consumption, Perseverance
- What is being tested?
- Simple physical task, Complex physical task and Cookies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to travel to laboratory around lunchtime for the study
- Willing to abstain from eating and drinking caloric beverages for at least 4 hours prior to completing the study
- Typically eats lunch
Who cannot join
- Diabetes, eating disorder, or any other condition that makes it unadvisable for participant to refrain from eating or drinking caloric beverages for 4 hours.
- Food allergies that would prevent participants from eating chocolate chip cookies or vegetables
- Pregnant or lactating
- Typically goes for longer than 5 hours (not counting sleep time) between meals and snacks
- Physical disabilities that would make it difficult for the participant to walk or to use their hands to grasp objects
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
Xiaomeng Xu, PhD, 401-793-8237, xxu1@lifespan.org
Tricia Leahey, PhD, 401-793-8947, tleahey@lifespan.org
About this study
This one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals.
- Conditions
- Food Consumption, Perseverance
- Being tested
- Simple physical task, Complex physical task, Cookies, Vegetables, No physical task
- Keywords
- taste test, food consumption, hunger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple physical taskBehavioural
Participants are asked to complete a 1-time simple physical task that is not challenging nor novel (moving small objects across a room).
Complex physical taskBehavioural
Participants are asked to complete a 1-time physical task that is low intensity but somewhat complex (involves a novel request to move objects in a way that is challenging and requires some coordination).
CookiesOther
Participants are asked to taste test chocolate chip cookies
VegetablesOther
Participants are asked to taste test raw celery or radishes
No physical taskBehavioural
As a control, for 2 of the arms, participants are not asked to engage in a physical task
| Study group | Role | What they receive |
|---|---|---|
| No physical task + Taste cookies | Active comparator | Participants in this arm do not engage in a physical activity task. They are asked to taste test chocolate chip cookies. Receives: Other: Cookies; Behavioral: No physical task |
| No physical task + Taste vegetable | Active comparator | Participant does not complete a physical activity. Asked to taste test raw celery or radishes. Receives: Other: Vegetables; Behavioral: No physical task |
| Simple physical task + Taste vegetables | Active comparator | Participants are asked to complete a simple physical task and are asked to taste test raw celery or radishes. Receives: Behavioral: Simple physical task; Other: Vegetables |
| Complex physical task + Taste vegetables | Active comparator | Participants complete a more complex physical task that is novel and challenging. They are asked to taste test raw celery or radishes. Receives: Behavioral: Complex physical task; Other: Vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical perseverance
as measured via maintained grip using a hand dynamometer on the dominant hand and set to 70% of participant's maximum grip strength
Measured: 1 hour
Secondary outcomes (3)
food preference
Food preference measured via participant's reported ratings after tasting different food.
Measured: 1 hour
Amount of food eaten
Amount of food that participants eat will be measured via a food scale at the end of the study.
Measured: 1 hour
Mood
Participant's subjective mood will be measured using a mood questionnaire (PANAS).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food ConsumptionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Xiaomeng Xu, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758302
- Sponsor's protocol ID
- 2T32HL076134-06XX
- Other IDs
- 2T32HL076134-06
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Laboratory Study Investigating How Physical Tasks and Hunger Affect Taste Perception
- ClinicalTrials.gov ID
- NCT01758302
- Acronym / sponsor ID
- 2T32HL076134-06XX
- Conditions
- Food Consumption, Perseverance
- Keywords
- taste test, food consumption, hunger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 1 Jan 2013 (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 one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No physical task + Taste cookies | Active comparator | Other: Cookies, Behavioral: No physical taskParticipants in this arm do not engage in a physical activity task. They are asked to taste test chocolate chip cookies. |
| No physical task + Taste vegetable | Active comparator | Other: Vegetables, Behavioral: No physical taskParticipant does not complete a physical activity. Asked to taste test raw celery or radishes. |
| Simple physical task + Taste vegetables | Active comparator | Behavioral: Simple physical task, Other: VegetablesParticipants are asked to complete a simple physical task and are asked to taste test raw celery or radishes. |
| Complex physical task + Taste vegetables | Active comparator | Behavioral: Complex physical task, Other: VegetablesParticipants complete a more complex physical task that is novel and challenging. They are asked to taste test raw celery or radishes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to travel to laboratory around lunchtime for the study
- Willing to abstain from eating and drinking caloric beverages for at least 4 hours prior to completing the study
- Typically eats lunch
Key exclusion criteria (5 listed)
- Diabetes, eating disorder, or any other condition that makes it unadvisable for participant to refrain from eating or drinking caloric beverages for 4 hours.
- Food allergies that would prevent participants from eating chocolate chip cookies or vegetables
- Pregnant or lactating
- Typically goes for longer than 5 hours (not counting sleep time) between meals and snacks
- Physical disabilities that would make it difficult for the participant to walk or to use their hands to grasp objects
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 |
|---|---|---|
| Simple physical taskParticipants are asked to complete a 1-time simple physical task that is not challenging nor novel (moving small objects across a room). | Behavioural | Simple physical task + Taste vegetables |
| Complex physical taskParticipants are asked to complete a 1-time physical task that is low intensity but somewhat complex (involves a novel request to move objects in a way that is challenging and requires some coordination). | Behavioural | Complex physical task + Taste vegetables |
| CookiesParticipants are asked to taste test chocolate chip cookies | Other | No physical task + Taste cookies |
| VegetablesParticipants are asked to taste test raw celery or radishes | Other | Complex physical task + Taste vegetables, No physical task + Taste vegetable, Simple physical task + Taste vegetables |
| No physical taskAs a control, for 2 of the arms, participants are not asked to engage in a physical task | Behavioural | No physical task + Taste cookies, No physical task + Taste vegetable |
Primary outcome
physical perseverance
Time frame: 1 hour
as measured via maintained grip using a hand dynamometer on the dominant hand and set to 70% of participant's maximum grip strength
3 secondary outcomes
food preference
Time frame: 1 hour
Amount of food eaten
Time frame: 1 hour
Mood
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
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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.
Xiaomeng Xu, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple physical task, Complex physical task and Cookies in people with Food Consumption and Perseverance, run by The Miriam Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 1 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomeng Xu, PhD (401-793-8237, xxu1@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical perseverance (time frame: 1 hour). 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 1 Jan 2013.