Efficacy and Safety of Hippophae Rhamnoides L. Leaf Extract on Body Fat

NCT ID: NCT02140697

Last Updated: 2016-05-16

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

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf Extract supplementation on body weight regulation in humans are lacking.

Detailed Description

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The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Hippophae rhamnoides L. Leaf Extract on body fat. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hippophae rhamnoides L. Leaf Extract

Hippophae rhamnoides L. Leaf Extract 3g/day

Group Type EXPERIMENTAL

Hippophae rhamnoides L. Leaf Extract (3g/day)

Intervention Type DIETARY_SUPPLEMENT

Hippophae rhamnoides L. Leaf extract (3g/day), parallel design

Placebo

Placebo 3g/day

Group Type PLACEBO_COMPARATOR

Placebo (3g/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo (3g/day), parallel design

Interventions

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Hippophae rhamnoides L. Leaf Extract (3g/day)

Hippophae rhamnoides L. Leaf extract (3g/day), parallel design

Intervention Type DIETARY_SUPPLEMENT

Placebo (3g/day)

Placebo (3g/day), parallel design

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* age between 19 and 65 years,
* BMI 25\~29.9 kg/m2 or Waist circumference ≥ 90(men), ≥ 85(women),
* subjects giving written informed consent

Exclusion Criteria

* BMI ≥ 30 kg/m2
* Significant variation in weight(more 10%) in the past 3 months
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding etc,.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SS-BF-HLE

Identifier Type: -

Identifier Source: org_study_id

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