AppetiteSATINNCT02270047
SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation
A study testing Orange nectar and Orange Nectar with fibre in people with Appetite, run by University of Copenhagen at 1 site in Denmark.
Trial summary
A 4 week double blinded parallel design with an intervention condition and a control condition will be employed. After having completed screening procedure and a baseline test day, participants will be randomized to either intervention or control condition. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Orange nectar and Orange Nectar with fibre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Mar 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have provided written informed consent
- BMI between 23.0-27.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
- Regular menstrual periods
Who cannot join
- Significant health problems as judged by the investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
- Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding
- History of anaphylaxis to food
- Any known food allergies or food intolerance, specifically the below listed:
- Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof;
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- Crustaceans and products thereof;
- Eggs and products thereof;
- Fish and products thereof;
- Peanuts and products thereof;
- Soybeans and products thereof;
- Milk and products thereof (including lactose);
- Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia), and products thereof, except for nuts used for making alcoholic distillates including ethyl alcohol of agricultural origin;
- Celery and products thereof;
- Mustard and products thereof;
- Sesame seeds and products thereof;
- Sulphur dioxide and sulphites;
- Lupin
- Molluscs
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator
- Significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator
- Use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator
- Participants who work in appetite or feeding related areas
- Participants not able to comply with the study protocol
- Post-menopausal
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition Exercise and Sports
Copenhagen, Copenhagen, 1958
About this study
A 4 week double blinded parallel design with an intervention condition and a control condition will be employed. After having completed screening procedure and a baseline test day, participants will be randomized to either intervention or control condition. In the following 4 weeks, the participants will have to consume the distributed food product daily before completing another test day.
- Conditions
- Appetite
- Being tested
- Orange nectar, Orange Nectar with fibre
- Keywords
- Ad libitum energy intake, Appetite sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange nectarDietary supplement
Orange nectar
Orange Nectar with fibreDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Orange nectar with NAXUS fibre, 5g/100mL Receives: Dietary Supplement: Orange Nectar with fibre |
| B | Placebo comparator | Orange nectar Receives: Dietary Supplement: Orange nectar |
What is being measured
The primary outcome is the main question the study is designed to answer.
AD libitum energy intake
Measured: week0, week 4
Secondary outcomes (1)
VAS score for appetite sensation
Perceptions of hunger, fullness, desire to eat, prospective consumption will be assessed using 100 mm VAS scales
Measured: Week 0, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Liverpool
- Responsible party
- Principal investigator, Anders Mikael Sjödin, MD, PHD ass professor, University of Copenhagen
- Investigators
- Graham Finlayson, Ass Prof, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270047
- Sponsor's protocol ID
- B315
- Acronym
- SATIN
- Status last verified
- Mar 2015
- First submitted
- 13 Oct 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation
- ClinicalTrials.gov ID
- NCT02270047
- Acronym / sponsor ID
- SATIN / B315
- Conditions
- Appetite
- Keywords
- Ad libitum energy intake, Appetite sensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Leeds, University of Liverpool
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Oct 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.
A 4 week double blinded parallel design with an intervention condition and a control condition will be employed. After having completed screening procedure and a baseline test day, participants will be randomized to either intervention or control condition. In the following 4 weeks, the participants will have to consume the distributed food product daily before completing another test day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: Orange Nectar with fibreOrange nectar with NAXUS fibre, 5g/100mL |
| B | Placebo comparator | Dietary Supplement: Orange nectarOrange nectar |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who have provided written informed consent
- BMI between 23.0-27.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
- Regular menstrual periods
Key exclusion criteria (27 listed)
- Significant health problems as judged by the investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
- Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding
- History of anaphylaxis to food
- Any known food allergies or food intolerance, specifically the below listed:
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 nectarOrange nectar | Dietary supplement | B |
| Orange Nectar with fibre | Dietary supplement | A |
Primary outcome
AD libitum energy intake
Time frame: week0, week 4
1 secondary outcome
VAS score for appetite sensation
Time frame: Week 0, week 4
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 Mar 2015.
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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.
Graham Finlayson, Ass Prof principal investigator
University of Liverpool
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 nectar and Orange Nectar with fibre in people with Appetite, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 27 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 Mar 2015. 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 Denmark. 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?
AD libitum energy intake (time frame: week0, week 4). 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 17 Mar 2015.