The Effects of Whole Versus Processed Orange Consumption on Satiety

A Randomized, Double Blind and Crossover Study Investigating the Effect of Whole Versus Processed Orange Consumption on Satiety in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Satiety Response
• Intervention / Treatment: Dietary supplement: Processed orange juice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Hugh Sinclair Unit of Human Nutrition

Participation Criteria

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(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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Water control (240 ml)	Dietary supplement: Processed orange juice; 3 different formulation of edible orange drinks
Experimental: Orange Juice; Orange juice, 240 ml. Commercial orange juice	Dietary supplement: Processed orange juice; 3 different formulation of edible orange drinks
Experimental: Whole orange; Whole orange, 240 ml. Whole orange, blended to include all edible orange material.	Dietary supplement: Processed orange juice; 3 different formulation of edible orange drinks
Experimental: processed orange juice; Processed orange juice, 240 ml. Experimental orange juice processing	Dietary supplement: Processed orange juice; 3 different formulation of edible orange drinks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: PepsiCo Global R&D
• Investigators: Principal Investigator: Jeremy P Spencer, PhD, University of Reading

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Estimate): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: UOR-0002