Self Reported Ratings of Hunger Clinical Trial
— POASOfficial title:
The Effect of Different Doses of Processed Whole Orange on Subjective Ratings of Satiety
| NCT number | NCT02116023 |
| Other study ID # | PEP-1402 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | April 10, 2014 |
| Last updated | October 27, 2014 |
| Start date | March 2014 |
| Verified date | October 2014 |
| Source | PepsiCo Global R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: N/A |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 21 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Reading | Reading |
| Lead Sponsor | Collaborator |
|---|---|
| PepsiCo Global R&D |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self reported ratings of hunger and fullness | 0-2 hours | No |