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

May 13, 2016 updated by: Soo-Wan Chae, Chonbuk National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
        • Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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,.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hippophae rhamnoides L. Leaf Extract
Hippophae rhamnoides L. Leaf Extract 3g/day
Dietary supplement: Hippophae rhamnoides L. Leaf Extract (3g/day)
Hippophae rhamnoides L. Leaf extract (3g/day), parallel design
Placebo Comparator: Placebo
Placebo 3g/day
Dietary supplement: Placebo (3g/day)
Placebo (3g/day), parallel design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body fat mass
Time Frame: Baseline and 12 week
Body fat mass was measured in study baseline and visit 3(12 week).
Baseline and 12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percent body fat
Time Frame: Baseline and 12 week
Percent body fat was measured in study baseline and visit 3(12 week).
Baseline and 12 week
Change in fat free mass
Time Frame: Baseline and 12 week
Fat Free Mass was measured in study baseline and visit 3(12 week).
Baseline and 12 week
Change in weight
Time Frame: Baseline and 12 week
Weight was measured in study baseline and visit 3(12 week).
Baseline and 12 week
Change in body mass index
Time Frame: Baseline and 12 week
Body mass index was measured in study baseline and visit 3(12 week).
Baseline and 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • SS-BF-HLE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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