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

Study Overview
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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

Intervention / Treatment
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* Dietary Supplement: Hippophae rhamnoides L. Leaf Extract (3g/day)
* Dietary Supplement: Placebo (3g/day)


Participation Criteria
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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,.

Ages Eligible for Study
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Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hippophae rhamnoides L. Leaf Extract<br>Hippophae rhamnoides L. Leaf Extract 3g/day | Dietary Supplement: Hippophae rhamnoides L. Leaf Extract (3g/day)<br>* Hippophae rhamnoides L. Leaf extract (3g/day), parallel design<br>|
| Placebo Comparator: Placebo<br>Placebo 3g/day | Dietary Supplement: Placebo (3g/day)<br>* Placebo (3g/day), parallel design<br>|

What is the study measuring?
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Primary Outcome Measures

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