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

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University of Copenhagen

Status

Completed

Conditions

Appetite

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

A
Active Comparator group
Description:
Orange nectar with NAXUS fibre, 5g/100mL
Treatment:
Dietary Supplement: Orange Nectar with fibre
B
Placebo Comparator group
Description:
Orange nectar
Treatment:
Dietary Supplement: Orange nectar

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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