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The Effects of Whole Versus Processed Orange Consumption on Satiety

NCT ID: NCT02288624

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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

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Satiety Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Water control (240 ml)

Group Type PLACEBO_COMPARATOR

Processed orange juice

Intervention Type DIETARY_SUPPLEMENT

3 different formulation of edible orange drinks

Orange Juice

Orange juice, 240 ml. Commercial orange juice

Group Type EXPERIMENTAL

Processed orange juice

Intervention Type DIETARY_SUPPLEMENT

3 different formulation of edible orange drinks

Whole orange

Whole orange, 240 ml. Whole orange, blended to include all edible orange material.

Group Type EXPERIMENTAL

Processed orange juice

Intervention Type DIETARY_SUPPLEMENT

3 different formulation of edible orange drinks

processed orange juice

Processed orange juice, 240 ml. Experimental orange juice processing

Group Type EXPERIMENTAL

Processed orange juice

Intervention Type DIETARY_SUPPLEMENT

3 different formulation of edible orange drinks

Interventions

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Processed orange juice

3 different formulation of edible orange drinks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor of nutritional medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy P Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UOR-0002

Identifier Type: -

Identifier Source: org_study_id