The Effects of Whole Versus Processed Orange Consumption on Satiety

NCT02288624 | Completed DMC

• 1 other identifier: UOR-0002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Satiety Response

Outcome Measures

Primary Outcomes (1)

• Self reported hunger and fullness score by Visual Analogue Scale

  baseline to 2 hours

Secondary Outcomes (1)

• Overall liking by '9 point hedonic scale'

  baseline to 2 hours

Study Arms (4)

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

Processed orange juice DIETARY_SUPPLEMENT

3 different formulation of edible orange drinks

Control; Orange Juice; Whole orange; processed orange juice

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• PepsiCo Global R&D: collaborator

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Study Officials

• Jeremy P Spencer, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of nutritional medicine

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: November 11, 2014
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

GB (1)