Clinical trial NCT02396615: SATIN WP4 Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng
Official title: SATIN WP4 - The Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Ad libitum energy intake
Appetite
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: University of Liverpool
First posted: 2015-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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)

Primary outcomes:
measure: Ad libitum energy intake
timeFrame: Baseline (week 0)
measure: Ad libitum energy intake
timeFrame: Test day 2 (week 1)
Secondary outcomes:
measure: VAS score for appetite sensation - hunger
timeFrame: Every 30 min during test day 1 and test day 2
measure: Eating behaviour questionnaire - binge eating scale
timeFrame: Screening
measure: Eating behaviour questionnaire - Control of Eating
timeFrame: screening
measure: Eating behaviour questionnaire - three factor eating questionnaire
timeFrame: screening
measure: Eating behaviour questionnaire- power of food
timeFrame: screening
measure: VAS score for appetite sensation - fullness
timeFrame: every 30 min during test day 1 and test day 2
measure: VAS score for appetite sensation - Desire to eat
timeFrame: every 30 min during test day 1 and test day 2
measure: VAS score for appetite sensation - prospective consumption
timeFrame: every 30 min during test day 1 and test day 2
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Frederiksberg
Study officials:
affiliation: University of Copenhagen
name: Anders Sjödin, Dr
role: PRINCIPAL_INVESTIGATOR
References: