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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02270047
Other study ID # B315
Secondary ID
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


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
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