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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo (3g/day); Dietary Supplement: Hippophae rhamnoides L. Leaf Extract (3g/day)

• Registration Number: NCT02140697
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (3g/day)	Placebo 3g/day
Hippophae rhamnoides L. Leaf Extract	Hippophae rhamnoides L. Leaf Extract (3g/day)	Hippophae rhamnoides L. Leaf Extract 3g/day

Primary Outcome Measures

Name	Time	Method
Changes in body fat mass	Baseline and 12 week	Body fat mass was measured in study baseline and visit 3(12 week).

Secondary Outcome Measures

Name	Time	Method
Change in weight	Baseline and 12 week	Weight 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 body mass index	Baseline and 12 week	Body mass index was measured in study baseline and visit 3(12 week).
Change in percent body fat	Baseline and 12 week	Percent body fat was measured in study baseline and visit 3(12 week).

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of