SATIN WP4 Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng

Healthy Clinical Trial

— SATIN  

Official title:

SATIN WP4 - The Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396615
• Other study ID #: B318
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: April 21, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: April 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

The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term.

Description:

A double-blind, randomised crossover design will be employed with an experimental (active) condition and a control condition at least one week apart. After having successfully completed screening procedures eligible participants will be invited for two separate test days, at least 7 days apart. On the two test days, the products will be provided in a randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be measured every 30 min for the following 8 hours. Satiety and satiation will be measured through administration of test meals in the laboratory supplied with controlled food intake under free-living conditions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participants who have provided written informed consent

• Healthy men and women

• Ages between 18 and 55 years

• BMI between 25.0-31.9 kg/m2

• Regular breakfast eaters (eating breakfast = 4 times a week)

• Regular menstrual periods (women only)

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 (women only)

• History of anaphylaxis to food

• Any known food allergies or food intolerance

• 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 (women only)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• SATIN pineapple
Active juice with added fibre and ginseng
• SATIN pineapple control
Control products without active ingredients

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Frederiksberg

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
Primary	Ad libitum energy intake	Total ad libitum energy intake during test day 1	Baseline (week 0)	No
Primary	Ad libitum energy intake	Total ad libitum energy intake during test day 2	Test day 2 (week 1)	No
Secondary	VAS score for appetite sensation - hunger	Perceptions of hunger, assessed using 100 mm VAS scales	Every 30 min during test day 1 and test day 2	No
Secondary	Eating behaviour questionnaire - binge eating scale	Questionnaire by Gormally et al. 1982	Screening	No
Secondary	Eating behaviour questionnaire - Control of Eating	Questionnaire by Hill et al. 1991	screening	No
Secondary	Eating behaviour questionnaire - three factor eating questionnaire	Three Factor Eating Questionnaire by Stunkard and Messick, 1985	screening	No
Secondary	Eating behaviour questionnaire- power of food	Power of food scale by Lowe et al 2009	screening	No
Secondary	VAS score for appetite sensation - fullness	Perceptions of fullness, assessed using 100 mm VAS scales	every 30 min during test day 1 and test day 2	No
Secondary	VAS score for appetite sensation - Desire to eat	Perceptions of Desire to eat, assessed using 100 mm VAS scales	every 30 min during test day 1 and test day 2	No
Secondary	VAS score for appetite sensation - prospective consumption	Perceptions of prospective suncumption, assessed using 100 mm VAS scales	every 30 min during test day 1 and test day 2	No