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

April 21, 2015 updated by: Anders Mikael Sjödin, MD, PHD ass professor, University of Copenhagen

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

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.

Study Overview

Detailed 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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 1958
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Satin pineapple. Active juice with fibre and ginseng
Active juice with added fibre and ginseng
Placebo Comparator: Control
SATIN pineapple control. Control juice - normal juice prpoducts without added active ingredients
Control products without active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad libitum energy intake
Time Frame: Baseline (week 0)
Total ad libitum energy intake during test day 1
Baseline (week 0)
Ad libitum energy intake
Time Frame: Test day 2 (week 1)
Total ad libitum energy intake during test day 2
Test day 2 (week 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score for appetite sensation - hunger
Time Frame: Every 30 min during test day 1 and test day 2
Perceptions of hunger, assessed using 100 mm VAS scales
Every 30 min during test day 1 and test day 2
Eating behaviour questionnaire - binge eating scale
Time Frame: Screening
Questionnaire by Gormally et al. 1982
Screening
Eating behaviour questionnaire - Control of Eating
Time Frame: screening
Questionnaire by Hill et al. 1991
screening
Eating behaviour questionnaire - three factor eating questionnaire
Time Frame: screening
Three Factor Eating Questionnaire by Stunkard and Messick, 1985
screening
Eating behaviour questionnaire- power of food
Time Frame: screening
Power of food scale by Lowe et al 2009
screening
VAS score for appetite sensation - fullness
Time Frame: every 30 min during test day 1 and test day 2
Perceptions of fullness, assessed using 100 mm VAS scales
every 30 min during test day 1 and test day 2
VAS score for appetite sensation - Desire to eat
Time Frame: every 30 min during test day 1 and test day 2
Perceptions of Desire to eat, assessed using 100 mm VAS scales
every 30 min during test day 1 and test day 2
VAS score for appetite sensation - prospective consumption
Time Frame: every 30 min during test day 1 and test day 2
Perceptions of prospective suncumption, assessed using 100 mm VAS scales
every 30 min during test day 1 and test day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anders Sjödin, Dr, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • B318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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