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

C

Chonbuk National University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02140697
SS-BF-HLE

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

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,.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

Hippophae rhamnoides L. Leaf Extract
Experimental group
Description:
Hippophae rhamnoides L. Leaf Extract 3g/day
Treatment:
Dietary Supplement: Hippophae rhamnoides L. Leaf Extract (3g/day)
Placebo
Placebo Comparator group
Description:
Placebo 3g/day
Treatment:
Dietary Supplement: Placebo (3g/day)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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