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OpenTrials
Completed

NCT Number: NCT02270047

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

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.

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Key information

Conditions

Appetite

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition Exercise and Sports

Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof;
  • Crustaceans and products thereof;
  • Eggs and products thereof;
  • Fish and products thereof;
  • Peanuts and products thereof;
  • Soybeans and products thereof;
  • Milk and products thereof (including lactose);
  • 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;
  • Celery and products thereof;
  • Mustard and products thereof;
  • Sesame seeds and products thereof;
  • Sulphur dioxide and sulphites;
  • Lupin
  • 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

Treatment and study plan

Orange nectar

Dietary Supplement

Orange nectar

Orange Nectar with fibre

Dietary Supplement

Primary outcomes

  1. AD libitum energy intake

    Time frame: week0, week 4

Secondary outcomes

  1. VAS score for appetite sensation

    Time frame: Week 0, week 4

    Perceptions of hunger, fullness, desire to eat, prospective consumption will be assessed using 100 mm VAS scales

Other outcomes

  1. Eating behaviour

    Time frame: week 0 week 4

    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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • University of Leeds
  • University of Liverpool

Registry information

Acronym: SATIN

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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