Satiety ResponseNCT02288624
The Effects of Whole Versus Processed Orange Consumption on Satiety
A study testing Processed orange juice in people with Satiety Response, run by University of Reading at 1 site in United Kingdom.
Trial summary
This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety Response
- What is being tested?
- Processed orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Jun 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: male or female(postmenopausal women only)
- Age at start of the study: males ≥ 21and ≤ 65 years and females ≥ 50 and ≤ 65 years
- 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, used to eating 3 meals a day
- Reported intense sporting activities ≤ 10h/w
Show all 9Show fewer
- Reported alcohol consumption ≤21 units/w
- Informed consent signed
- Recruitment form filled out
Who cannot join
- Smoking
- 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
- Pre menopausal women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP
About this study
Official title: A Randomized, Double Blind and Crossover Study Investigating the Effect of Whole Versus Processed Orange Consumption on Satiety in Healthy Volunteers
This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.
Read the detailed description
This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.
- Conditions
- Satiety Response
- Being tested
- Processed orange juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed orange juiceDietary supplement
3 different formulation of edible orange drinks
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Water control (240 ml) Receives: Dietary Supplement: Processed orange juice |
| Orange Juice | Experimental | Orange juice, 240 ml. Commercial orange juice Receives: Dietary Supplement: Processed orange juice |
| Whole orange | Experimental | Whole orange, 240 ml. Whole orange, blended to include all edible orange material. Receives: Dietary Supplement: Processed orange juice |
| processed orange juice | Experimental | Processed orange juice, 240 ml. Experimental orange juice processing Receives: Dietary Supplement: Processed orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported hunger and fullness score by Visual Analogue Scale
Measured: baseline to 2 hours
Secondary outcomes (1)
Overall liking by '9 point hedonic scale'
Measured: baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satiety ResponseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy P Spencer, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288624
- Sponsor's protocol ID
- UOR-0002
- Status last verified
- Nov 2014
- First submitted
- 16 Jan 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind and Crossover Study Investigating the Effect of Whole Versus Processed Orange Consumption on Satiety in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02288624
- Acronym / sponsor ID
- UOR-0002
- Conditions
- Satiety Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Nov 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.
This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.
Detailed description
This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Processed orange juiceWater control (240 ml) |
| Orange Juice | Experimental | Dietary Supplement: Processed orange juiceOrange juice, 240 ml. Commercial orange juice |
| Whole orange | Experimental | Dietary Supplement: Processed orange juiceWhole orange, 240 ml. Whole orange, blended to include all edible orange material. |
| processed orange juice | Experimental | Dietary Supplement: Processed orange juiceProcessed orange juice, 240 ml. Experimental orange juice processing |
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(postmenopausal women only)
- Age at start of the study: males ≥ 21and ≤ 65 years and females ≥ 50 and ≤ 65 years
- 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, used to eating 3 meals a day
Key exclusion criteria (6 listed)
- Smoking
- 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
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 |
|---|---|---|
| Processed orange juice3 different formulation of edible orange drinks | Dietary supplement | Control, Orange Juice, Whole orange, processed orange juice |
Primary outcome
Self reported hunger and fullness score by Visual Analogue Scale
Time frame: baseline to 2 hours
1 secondary outcome
Overall liking by '9 point hedonic scale'
Time frame: baseline to 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 11 Nov 2014.
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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.
Jeremy P Spencer, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed orange juice in people with Satiety Response, run by University of Reading 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 6 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 11 Nov 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 hunger and fullness score by Visual Analogue Scale (time frame: baseline to 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 11 Nov 2014.