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

NCT ID: NCT02270047

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A

Orange nectar with NAXUS fibre, 5g/100mL

Group Type: ACTIVE_COMPARATOR

Orange Nectar with fibre

Intervention Type: DIETARY_SUPPLEMENT

B

Orange nectar

Group Type: PLACEBO_COMPARATOR

Orange nectar

Intervention Type: DIETARY_SUPPLEMENT

Orange nectar

Interventions

Orange nectar

Orange nectar

Intervention Type: DIETARY_SUPPLEMENT

Orange Nectar with fibre

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Anders Mikael Sjödin, MD, PHD ass professor

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Graham Finlayson, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

Department of Nutrition Exercise and Sports

Copenhagen, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

B315

Identifier Type: -

Identifier Source: org_study_id