Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.

Study Overview
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Brief Summary
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The aim of this study is to investigate the effects of immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.

Detailed Description
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This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.

Official Title
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Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: immature ponkan (Citrus reticulate) extract
* Dietary Supplement: placebo
* Behavioral: time restricted feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female aged 20-60 years old body mass index is greater than or equal to 24 kg/m2, or body fat more than 30% Exclusion Criteria: Subjects diagnosed with cancer and on curative care. Subjects diagnosed with heart disease and on curative care. Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug. Subjects with systemic infection requiring antibiotics.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day. | Dietary Supplement: placebo<br>* Drink 25mL for once, and once a day.<br>|
| Experimental: immature ponkan (Citrus reticulate) extract<br>Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day. | Dietary Supplement: immature ponkan (Citrus reticulate) extract<br>* Drink 25mL for once, and once a day.<br>|
| Experimental: immature ponkan (Citrus reticulate) extract with time restricted feeding<br>Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding. | Dietary Supplement: immature ponkan (Citrus reticulate) extract<br>* Drink 25mL for once, and once a day.<br>Behavioral: time restricted feeding<br>* Controlling a shortened period of time for eating within 8 hour each day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline body weight at week 8 | Compared the difference of body weight between the week 8 and 0. | Week 0, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline body fat at week 8 | Compared the difference of body fat between the week 8 and 0. | Week 0, Week 8 |