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

Study Overview
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Brief Summary
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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.

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

Conditions
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Appetite

Intervention / Treatment
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* Dietary Supplement: Orange nectar
* Dietary Supplement: Orange Nectar with fibre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Orange nectar with NAXUS fibre, 5g/100mL | Dietary Supplement: Orange Nectar with fibre<br> <br> |
| Placebo Comparator: B<br>Orange nectar | Dietary Supplement: Orange nectar<br>* Orange nectar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ad libitum energy intake, Appetite sensation