NCT02396615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

February 19, 2015

Last Update Submit

April 21, 2015

Conditions

Healthy

Keywords

Ad libitum energy intakeAppetite

Outcome Measures

Primary Outcomes (2)

  • Ad libitum energy intake

    Total ad libitum energy intake during test day 1

    Baseline (week 0)

  • Ad libitum energy intake

    Total ad libitum energy intake during test day 2

    Test day 2 (week 1)

Secondary Outcomes (8)

  • VAS score for appetite sensation - hunger

    Every 30 min during test day 1 and test day 2

  • Eating behaviour questionnaire - binge eating scale

    Screening

  • Eating behaviour questionnaire - Control of Eating

    screening

  • Eating behaviour questionnaire - three factor eating questionnaire

    screening

  • Eating behaviour questionnaire- power of food

    screening

  • +3 more secondary outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

Satin pineapple. Active juice with fibre and ginseng

Dietary Supplement: SATIN pineapple

Control

PLACEBO COMPARATOR

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

Dietary Supplement: SATIN pineapple control

Interventions

SATIN pineappleDIETARY_SUPPLEMENT

Active juice with added fibre and ginseng

Active
SATIN pineapple controlDIETARY_SUPPLEMENT

Control products without active ingredients

Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

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 (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Frederiksberg, 1958, Denmark

Location

Study Officials

  • Anders Sjödin, Dr

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, PhD, Associate Professor,

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 24, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

DK(1)