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

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.

Study Overview

• Status: Completed
• Conditions: Appetite
• Intervention / Treatment: Dietary supplement: Orange Nectar with fibre; Dietary supplement: Orange nectar

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1958
    • Department of Nutrition Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Orange nectar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AD libitum energy intake	week0, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: University of Leeds; University of Liverpool
• Investigators: Principal Investigator: Graham Finlayson, Ass Prof, University of Liverpool

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (ESTIMATE): October 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Ad libitum energy intake; Appetite sensation
• Other Study ID Numbers: B315