- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02396615
SATIN WP4 Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng (SATIN)
April 21, 2015 updated by: Anders Mikael Sjödin, MD, PHD ass professor, University of Copenhagen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Frederiksberg
-
Copenhagen, Frederiksberg, Denmark, 1958
- University of Copenhagen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active
Satin pineapple.
Active juice with fibre and ginseng
|
Active juice with added fibre and ginseng
|
Placebo Comparator: Control
SATIN pineapple control.
Control juice - normal juice prpoducts without added active ingredients
|
Control products without active ingredients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ad libitum energy intake
Time Frame: Baseline (week 0)
|
Total ad libitum energy intake during test day 1
|
Baseline (week 0)
|
Ad libitum energy intake
Time Frame: Test day 2 (week 1)
|
Total ad libitum energy intake during test day 2
|
Test day 2 (week 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score for appetite sensation - hunger
Time Frame: Every 30 min during test day 1 and test day 2
|
Perceptions of hunger, assessed using 100 mm VAS scales
|
Every 30 min during test day 1 and test day 2
|
Eating behaviour questionnaire - binge eating scale
Time Frame: Screening
|
Questionnaire by Gormally et al. 1982
|
Screening
|
Eating behaviour questionnaire - Control of Eating
Time Frame: screening
|
Questionnaire by Hill et al. 1991
|
screening
|
Eating behaviour questionnaire - three factor eating questionnaire
Time Frame: screening
|
Three Factor Eating Questionnaire by Stunkard and Messick, 1985
|
screening
|
Eating behaviour questionnaire- power of food
Time Frame: screening
|
Power of food scale by Lowe et al 2009
|
screening
|
VAS score for appetite sensation - fullness
Time Frame: every 30 min during test day 1 and test day 2
|
Perceptions of fullness, assessed using 100 mm VAS scales
|
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
|
Perceptions of Desire to eat, assessed using 100 mm VAS scales
|
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
|
Perceptions of prospective suncumption, assessed using 100 mm VAS scales
|
every 30 min during test day 1 and test day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anders Sjödin, Dr, University of Copenhagen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
February 19, 2015
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B318
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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