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

NCT ID: NCT02396615

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-04-30

Brief 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.

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Active

Satin pineapple. Active juice with fibre and ginseng

Group Type: ACTIVE_COMPARATOR

SATIN pineapple

Intervention Type: DIETARY_SUPPLEMENT

Active juice with added fibre and ginseng

Control

SATIN pineapple control. Control juice - normal juice prpoducts without added active ingredients

Group Type: PLACEBO_COMPARATOR

SATIN pineapple control

Intervention Type: DIETARY_SUPPLEMENT

Control products without active ingredients

Interventions

SATIN pineapple

Active juice with added fibre and ginseng

Intervention Type: DIETARY_SUPPLEMENT

SATIN pineapple control

Control products without active ingredients

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Anders Mikael Sjödin, MD, PHD ass professor

Dr, PhD, Associate Professor,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Sjödin, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

University of Copenhagen

Copenhagen, Frederiksberg, Denmark

Countries

Denmark

Other Identifiers

B318

Identifier Type: -

Identifier Source: org_study_id