- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02116023
The Effects of Processed Whole Orange on Subjective Ratings of Satiety (POAS)
October 27, 2014 updated by: PepsiCo Global R&D
The Effect of Different Doses of Processed Whole Orange on Subjective Ratings of Satiety
The study is a human dietary test meal study that is a randomized, controlled, double blind, cross over design with 3 intervention arms that will investigate the subjective ratings of satiety in response to different levels of processed whole orange compared with a sugar-matched isocaloric control
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
-
-
-
Reading, United Kingdom, RG6 6UR
- University of Reading
-
-
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
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Gender: male or female
- Age at start of the study: males and females ≥ 21and ≤ 65 years
- Females taking contraceptive pill or post menopausal
- Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
- Apparently healthy: measured by questionnaire, no reported current or previous -metabolic diseases or chronic gastrointestinal disorders
- Reported dietary habits: no medically prescribed diet, no slimming diet within the past 3 months, used to eating 3 meals a day
- Reported intense sporting activities ≤ 10h/w
- Reported alcohol consumption ≤21 units/w Informed consent signed
- Recruitment form filled out
Exclusion Criteria:
- Smoking
- Premenopausal females not taking the contraceptive pill
- Dislike, allergy or intolerance to test products
- Possible eating disorder (measured by SCOFF questionnaire score >1)
- Eating habits questionnaire score >14
- Reported medical treatment that may affect eating habits/satiety
- Food allergies or intolerance
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Orange flavored beverage - Test1
240ml processed whole orange low dose
|
|
|
Experimental: Orange flavored beverage - Test2
240ml processed whole orange high dose
|
|
|
Placebo Comparator: Orange flavored beverage - Placebo
240ml orange beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self reported ratings of hunger and fullness
Time Frame: 0-2 hours
|
0-2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
April 10, 2014
First Submitted That Met QC Criteria
April 14, 2014
First Posted (Estimate)
April 16, 2014
Study Record Updates
Last Update Posted (Estimate)
October 28, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PEP-1402
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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