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

NCT02270047 | Completed

• 1 other identifier: B315
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Ad libitum energy intake; Appetite sensation

Outcome Measures

Primary Outcomes (1)

• AD libitum energy intake

  week0, week 4

Secondary Outcomes (1)

• VAS score for appetite sensation

  Week 0, week 4

Other Outcomes (1)

• Eating behaviour

  week 0 week 4

Study Arms (2)

A

ACTIVE COMPARATOR

Orange nectar with NAXUS fibre, 5g/100mL

Dietary Supplement: Orange Nectar with fibre

B

PLACEBO COMPARATOR

Orange nectar

Dietary Supplement: Orange nectar

Interventions

Orange nectar DIETARY_SUPPLEMENT

Orange nectar

B

Orange Nectar with fibre DIETARY_SUPPLEMENT

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Leeds: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Department of Nutrition Exercise and Sports

Copenhagen, Copenhagen, 1958, Denmark

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Graham Finlayson, Ass Prof

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 21, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

DK (1)