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

Chung Shan Medical University

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: time restricted feeding; Dietary Supplement: placebo; Dietary Supplement: immature ponkan (Citrus reticulate) extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05620667

CS2-22066

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.

Treatment:

Dietary Supplement: placebo

immature ponkan (Citrus reticulate) extract

Experimental group

Description:

Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.

Treatment:

Dietary Supplement: immature ponkan (Citrus reticulate) extract

immature ponkan (Citrus reticulate) extract with time restricted feeding

Experimental group

Description:

Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.

Treatment:

Behavioral: time restricted feeding

Dietary Supplement: immature ponkan (Citrus reticulate) extract