Self Reported Ratings of HungerPOASNCT02116023
The Effects of Processed Whole Orange on Subjective Ratings of Satiety
A study testing Orange flavored beverage in people with Self Reported Ratings of Hunger, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
The study is a human dietary test meal study that is a randomized, controlled, double blind, cross over design with 3 intervention arms that will investigate the subjective ratings of satiety in response to different levels of processed whole orange compared with a sugar-matched isocaloric control Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Reported Ratings of Hunger
- What is being tested?
- Orange flavored beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Jul 2014
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: male or female
- Age at start of the study: males and females ≥ 21and ≤ 65 years
- Females taking contraceptive pill or post menopausal
- Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
- Apparently healthy: measured by questionnaire, no reported current or previous -metabolic diseases or chronic gastrointestinal disorders
- Reported dietary habits: no medically prescribed diet, no slimming diet within the past 3 months, used to eating 3 meals a day
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- Reported intense sporting activities ≤ 10h/w
- Reported alcohol consumption ≤21 units/w Informed consent signed
- Recruitment form filled out
Who cannot join
- Smoking
- Premenopausal females not taking the contraceptive pill
- Dislike, allergy or intolerance to test products
- Possible eating disorder (measured by SCOFF questionnaire score >1)
- Eating habits questionnaire score >14
- Reported medical treatment that may affect eating habits/satiety
- Food allergies or intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Doses of Processed Whole Orange on Subjective Ratings of Satiety
The study is a human dietary test meal study that is a randomized, controlled, double blind, cross over design with 3 intervention arms that will investigate the subjective ratings of satiety in response to different levels of processed whole orange compared with a sugar-matched isocaloric control
- Conditions
- Self Reported Ratings of Hunger
- Being tested
- Orange flavored beverage
- Keywords
- Satiety, beverage, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange flavored beverageOther
| Study group | Role | What they receive |
|---|---|---|
| Orange flavored beverage - Test1 | Experimental | 240ml processed whole orange low dose Receives: Other: Orange flavored beverage |
| Orange flavored beverage - Test2 | Experimental | 240ml processed whole orange high dose Receives: Other: Orange flavored beverage |
| Orange flavored beverage - Placebo | Placebo comparator | 240ml orange beverage Receives: Other: Orange flavored beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported ratings of hunger and fullness
Measured: 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self Reported Ratings of HungerStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116023
- Sponsor's protocol ID
- PEP-1402
- Acronym
- POAS
- Status last verified
- Oct 2014
- First submitted
- 10 Apr 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Processed Whole Orange on Subjective Ratings of Satiety
- ClinicalTrials.gov ID
- NCT02116023
- Acronym / sponsor ID
- POAS / PEP-1402
- Conditions
- Self Reported Ratings of Hunger
- Keywords
- Satiety, beverage, crossover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 16 Apr 2014 (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 study is a human dietary test meal study that is a randomized, controlled, double blind, cross over design with 3 intervention arms that will investigate the subjective ratings of satiety in response to different levels of processed whole orange compared with a sugar-matched isocaloric control
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orange flavored beverage - Test1 | Experimental | Other: Orange flavored beverage240ml processed whole orange low dose |
| Orange flavored beverage - Test2 | Experimental | Other: Orange flavored beverage240ml processed whole orange high dose |
| Orange flavored beverage - Placebo | Placebo comparator | Other: Orange flavored beverage240ml orange beverage |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gender: male or female
- Age at start of the study: males and females ≥ 21and ≤ 65 years
- Females taking contraceptive pill or post menopausal
- Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
- Apparently healthy: measured by questionnaire, no reported current or previous -metabolic diseases or chronic gastrointestinal disorders
Key exclusion criteria (7 listed)
- Smoking
- Premenopausal females not taking the contraceptive pill
- Dislike, allergy or intolerance to test products
- Possible eating disorder (measured by SCOFF questionnaire score >1)
- Eating habits questionnaire score >14
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 |
|---|---|---|
| Orange flavored beverage | Other | Orange flavored beverage - Placebo, Orange flavored beverage - Test1, Orange flavored beverage - Test2 |
Primary outcome
Self reported ratings of hunger and fullness
Time frame: 0-2 hours
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 28 Oct 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange flavored beverage in people with Self Reported Ratings of Hunger, run by PepsiCo Global R&D at 1 site in United Kingdom.
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 9 inclusion and 7 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 28 Oct 2014. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Self reported ratings of hunger and fullness (time frame: 0-2 hours). 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 28 Oct 2014.