Obesity
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTHippophae rhamnoides L. Leaf Extract (3g/day)
Hippophae rhamnoides L. Leaf extract (3g/day), parallel design
DIETARY_SUPPLEMENTPlacebo (3g/day)
Placebo (3g/day), parallel design
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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,.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body fat mass | Baseline and 12 week | Body fat mass was measured in study baseline and visit 3(12 week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent body fat | Baseline and 12 week | Percent body fat was measured in study baseline and visit 3(12 week). |
| Change in fat free mass | Baseline and 12 week | Fat Free Mass was measured in study baseline and visit 3(12 week). |
| Change in weight | Baseline and 12 week | Weight was measured in study baseline and visit 3(12 week). |
| Change in body mass index | Baseline and 12 week | Body mass index was measured in study baseline and visit 3(12 week). |
Countries
South Korea
Outcome results
None listed