The Effects of Processed Whole Orange on Subjective Ratin... | NCT02116023

Studies
The Effects of Processed Whole Orange on Subjective Ratings of Satiety

NCT02116023

Sponsor

PepsiCo Global R&D

Status

Completed

Last Update Posted

Oct 28, 2014Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Self Reported Ratings of Hunger

Interventions

Orange flavored beverage

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Not provided

First Submitted Date

Apr 10, 2014

First Submission Date that Met QC Criteria

Apr 14, 2014

First Posted Date

Apr 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2014

Last Update Posted Date

Oct 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orange flavored beverage - Test1	Experimental	240ml processed whole orange low dose	Other: Orange flavored beverage
Orange flavored beverage - Test2	Experimental	240ml processed whole orange high dose	Other: Orange flavored beverage
Orange flavored beverage - Placebo	Placebo Comparator	240ml orange beverage	Other: Orange flavored beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orange flavored beverage	Other		Orange flavored beverage - Placebo Orange flavored beverage - Test1 Orange flavored beverage - Test2

Measure	Description	Time Frame
Self reported ratings of hunger and fullness		0-2 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided