Clinical trial NCT02270047: SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation
Official title: SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Keywords: Ad libitum energy intake
Appetite sensation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: University of Liverpool
First posted: 2014-10-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: AD libitum energy intake
timeFrame: week0, week 4
Secondary outcomes:
measure: VAS score for appetite sensation
timeFrame: Week 0, week 4
Other outcomes:
measure: Eating behaviour
timeFrame: week 0 week 4
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition Exercise and Sports
Study officials:
affiliation: University of Liverpool
name: Graham Finlayson, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: