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CompletedNCT02270047SATINUpdated Mar 17, 2015

SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation

An interventional study of Orange nectar and Orange Nectar with fibre in Appetite, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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. In the following 4 weeks, the participants will have to consume the distributed food product daily before completing another test day.

02

Conditions studied

  • Appetite

Keywords

  • Ad libitum energy intake
  • Appetite sensation
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

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
  • History of anaphylaxis to food
  • Any known food allergies or food intolerance, specifically the below listed:

    1. Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof;
    2. Crustaceans and products thereof;
    3. Eggs and products thereof;
    4. Fish and products thereof;
    5. Peanuts and products thereof;
    6. Soybeans and products thereof;
    7. Milk and products thereof (including lactose);
    8. 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;
    9. Celery and products thereof;
    10. Mustard and products thereof;
    11. Sesame seeds and products thereof;
    12. Sulphur dioxide and sulphites;
    13. Lupin
    14. 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    A

    Orange nectar with NAXUS fibre, 5g/100mL

    Dietary Supplement: Orange Nectar with fibre

  • Placebo comparator
    B

    Orange nectar

    Dietary Supplement: Orange nectar

Interventions

  • Dietary supplementOrange nectar

    Orange nectar

  • Dietary supplementOrange Nectar with fibre
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What researchers measure

Primary outcomes

  1. AD libitum energy intake

    Time frame: 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

    Time frame: Week 0, week 4

Other outcomes

  1. Eating behaviour

    Eating behaviour will be assessed by the binge eating scale from Gormally et al. 1982, the Control og Eating questionnaire by Hill et al. 1991, the Power og food scale by Lowe et al 2009, and the Three Factor Eating Questionnaire by Stunkard and Messick, 1985

    Time frame: week 0 week 4

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Study locations

1 site
  • Department of Nutrition Exercise and Sports
    Copenhagen, 1958, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02270047
Lead sponsor
University of Copenhagen
Collaborators
University of Leeds, University of Liverpool
Responsible party
Anders Mikael Sjödin, MD, PHD ass professor (Associated Professor, University of Copenhagen) — Principal investigator
First posted
Oct 21, 2014
Start date
Dec 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 17, 2015

Study contacts

Graham Finlayson, Ass Prof
principal investigator · University of Liverpool

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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