HealthySATINNCT02396615
SATIN WP4 Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng
A study testing SATIN pineapple in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SATIN pineapple
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Apr 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have provided written informed consent
- Healthy men and women
- Ages between 18 and 55 years
- BMI between 25.0-31.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
- Regular menstrual periods (women only)
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 (women only)
- History of anaphylaxis to food
- Any known food allergies or food intolerance
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
Show all 13Show fewer
- 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 (women only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SATIN WP4 - The Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng
The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term.
Read the detailed description
A double-blind, randomised crossover design will be employed with an experimental (active) condition and a control condition at least one week apart. After having successfully completed screening procedures eligible participants will be invited for two separate test days, at least 7 days apart. On the two test days, the products will be provided in a randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be measured every 30 min for the following 8 hours. Satiety and satiation will be measured through administration of test meals in the laboratory supplied with controlled food intake under free-living conditions
- Conditions
- Healthy
- Being tested
- SATIN pineapple, SATIN pineapple control
- Keywords
- Ad libitum energy intake, Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SATIN pineappleDietary supplement
Active juice with added fibre and ginseng
SATIN pineapple controlDietary supplement
Control products without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Satin pineapple. Active juice with fibre and ginseng Receives: Dietary Supplement: SATIN pineapple |
| Control | Placebo comparator | SATIN pineapple control. Control juice - normal juice prpoducts without added active ingredients Receives: Dietary Supplement: SATIN pineapple control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum energy intake
Total ad libitum energy intake during test day 1
Measured: Baseline (week 0)
Ad libitum energy intake
Total ad libitum energy intake during test day 2
Measured: Test day 2 (week 1)
Secondary outcomes (8)
VAS score for appetite sensation - hunger
Perceptions of hunger, assessed using 100 mm VAS scales
Measured: Every 30 min during test day 1 and test day 2
Eating behaviour questionnaire - binge eating scale
Questionnaire by Gormally et al. 1982
Measured: Screening
Eating behaviour questionnaire - Control of Eating
Questionnaire by Hill et al. 1991
Measured: screening
Eating behaviour questionnaire - three factor eating questionnaire
Three Factor Eating Questionnaire by Stunkard and Messick, 1985
Measured: screening
Eating behaviour questionnaire- power of food
Power of food scale by Lowe et al 2009
Measured: screening
VAS score for appetite sensation - fullness
Perceptions of fullness, assessed using 100 mm VAS scales
Measured: every 30 min during test day 1 and test day 2
VAS score for appetite sensation - Desire to eat
Perceptions of Desire to eat, assessed using 100 mm VAS scales
Measured: every 30 min during test day 1 and test day 2
VAS score for appetite sensation - prospective consumption
Perceptions of prospective suncumption, assessed using 100 mm VAS scales
Measured: every 30 min during test day 1 and test day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 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
- Anders Sjödin, Dr, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396615
- Sponsor's protocol ID
- B318
- Acronym
- SATIN
- Status last verified
- Apr 2015
- First submitted
- 19 Feb 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SATIN WP4 - The Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng
- ClinicalTrials.gov ID
- NCT02396615
- Acronym / sponsor ID
- SATIN / B318
- Conditions
- Healthy
- Keywords
- Ad libitum energy intake, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Leeds, University of Liverpool
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Mar 2015 (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 objective of the study is to establish whether a Pineapple juice with Viscofiber and Red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term.
Detailed description
A double-blind, randomised crossover design will be employed with an experimental (active) condition and a control condition at least one week apart. After having successfully completed screening procedures eligible participants will be invited for two separate test days, at least 7 days apart. On the two test days, the products will be provided in a randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be measured every 30 min for the following 8 hours. Satiety and satiation will be measured through administration of test meals in the laboratory supplied with controlled food intake under free-living conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: SATIN pineappleSatin pineapple. Active juice with fibre and ginseng |
| Control | Placebo comparator | Dietary Supplement: SATIN pineapple controlSATIN pineapple control. Control juice - normal juice prpoducts without added active ingredients |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who have provided written informed consent
- Healthy men and women
- Ages between 18 and 55 years
- BMI between 25.0-31.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Key exclusion criteria (13 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 (women only)
- History of anaphylaxis to food
- Any known food allergies or food intolerance
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 |
|---|---|---|
| SATIN pineappleActive juice with added fibre and ginseng | Dietary supplement | Active |
| SATIN pineapple controlControl products without active ingredients | Dietary supplement | Control |
Primary outcome
Ad libitum energy intake
Time frame: Baseline (week 0)
Total ad libitum energy intake during test day 1
Ad libitum energy intake
Time frame: Test day 2 (week 1)
Total ad libitum energy intake during test day 2
8 secondary outcomes
VAS score for appetite sensation - hunger
Time frame: Every 30 min during test day 1 and test day 2
Eating behaviour questionnaire - binge eating scale
Time frame: Screening
Eating behaviour questionnaire - Control of Eating
Time frame: screening
Eating behaviour questionnaire - three factor eating questionnaire
Time frame: screening
Eating behaviour questionnaire- power of food
Time frame: screening
VAS score for appetite sensation - fullness
Time frame: every 30 min during test day 1 and test day 2
VAS score for appetite sensation - Desire to eat
Time frame: every 30 min during test day 1 and test day 2
VAS score for appetite sensation - prospective consumption
Time frame: every 30 min during test day 1 and test day 2
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 22 Apr 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.
Anders Sjödin, Dr principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SATIN pineapple in people with Healthy, 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 6 inclusion and 13 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 22 Apr 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: Baseline (week 0)). 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 22 Apr 2015.