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

Appetite Clinical Trial

— SATIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270047
• Other study ID #: B315
• Status: Completed
• Phase: N/A
• First received: October 13, 2014
• Last updated: March 16, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appetite

Intervention

Dietary Supplement:
• Orange nectar
Orange nectar
• Orange Nectar with fibre

Locations

Country	Name	City	State
Denmark	Department of Nutrition Exercise and Sports	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	University of Leeds, University of Liverpool

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	week 0 week 4	No
Primary	AD libitum energy intake		week0, week 4	No
Secondary	VAS score for appetite sensation	Perceptions of hunger, fullness, desire to eat, prospective consumption will be assessed using 100 mm VAS scales	Week 0, week 4	No