The Effects of Whole Versus Processed Orange Consumption on Satiety

Study Overview
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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.

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

Conditions
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Satiety Response

Intervention / Treatment
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* Dietary Supplement: Processed orange juice


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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