The Effects of Whole Versus Processed Orange Consumption... | NCT02288624

Studies
The Effects of Whole Versus Processed Orange Consumption on Satiety

NCT02288624

Sponsor

University of Reading

Status

Completed

Last Update Posted

Nov 11, 2014Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Satiety Response

Interventions

Processed orange juice

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

Nov 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

Apr 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Nov 10, 2014

First Posted Date

Nov 11, 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

Nov 10, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Name	Class
PepsiCo Global R&D	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.

Detailed Description

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Water control (240 ml)	Dietary Supplement: Processed orange juice
Orange Juice	Experimental	Orange juice, 240 ml. Commercial orange juice	Dietary Supplement: Processed orange juice
Whole orange	Experimental	Whole orange, 240 ml. Whole orange, blended to include all edible orange material.	Dietary Supplement: Processed orange juice
processed orange juice	Experimental	Processed orange juice, 240 ml. Experimental orange juice processing	Dietary Supplement: Processed orange juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Processed orange juice	Dietary Supplement	3 different formulation of edible orange drinks	Control Orange Juice Whole orange processed orange juice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self reported hunger and fullness score by Visual Analogue Scale		baseline to 2 hours

Secondary Outcomes

Measure	Description	Time Frame
Overall liking by '9 point hedonic scale'		baseline to 2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gender: male or female(postmenopausal women only)
Age at start of the study: males ≥ 21and ≤ 65 years and females ≥ 50 and ≤ 65 years
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, 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
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
Pre menopausal women

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy P Spencer, PhD	University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hugh Sinclair Unit of Human Nutrition		Reading	Berkshire	RG6 6AP	United Kingdom