The Effects of Whole Versus Processed Orange Consumption on Satiety

Satiety Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288624
• Other study ID #: UOR-0002
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: November 10, 2014
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Satiety Response

Intervention

Dietary Supplement:
• Processed orange juice
3 different formulation of edible orange drinks

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	PepsiCo Global R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported hunger and fullness score by Visual Analogue Scale		baseline to 2 hours	No
Secondary	Overall liking by '9 point hedonic scale'		baseline to 2 hours	No