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The Effects of Whole Versus Processed Orange Consumption on Satiety

Sponsor
University of Reading (Other)
Overall Status
Completed
CT.gov ID
NCT02288624
Collaborator
PepsiCo Global R&D (Industry)
24
Enrollment
1
Location
4
Arms
14
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Processed orange juice
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double Blind and Crossover Study Investigating the Effect of Whole Versus Processed Orange Consumption on Satiety in Healthy Volunteers
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Self reported hunger and fullness score by Visual Analogue Scale [baseline to 2 hours]

Secondary Outcome Measures

  1. Overall liking by '9 point hedonic scale' [baseline to 2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hugh Sinclair Unit of Human Nutrition Reading Berkshire United Kingdom RG6 6AP

Sponsors and Collaborators

  • University of Reading
  • PepsiCo Global R&D

Investigators

  • Principal Investigator: Jeremy P Spencer, PhD, University of Reading

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeremy Paul Edward Spencer, Professor of nutritional medicine, University of Reading
ClinicalTrials.gov Identifier:
NCT02288624
Other Study ID Numbers:
  • UOR-0002
First Posted:
Nov 11, 2014
Last Update Posted:
Nov 11, 2014
Last Verified:
Nov 1, 2014

Study Results

No Results Posted as of Nov 11, 2014