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OpenTrials
Completed

NCT Number: NCT02140697

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,.

Treatment and study plan

Hippophae rhamnoides L. Leaf Extract (3g/day)

Dietary Supplement

Hippophae rhamnoides L. Leaf extract (3g/day), parallel design

Placebo (3g/day)

Dietary Supplement

Placebo (3g/day), parallel design

Primary outcomes

  1. Changes in body fat mass

    Time frame: Baseline and 12 week

    Body fat mass was measured in study baseline and visit 3(12 week).

Secondary outcomes

  1. Change in percent body fat

    Time frame: Baseline and 12 week

    Percent body fat was measured in study baseline and visit 3(12 week).

  2. Change in fat free mass

    Time frame: Baseline and 12 week

    Fat Free Mass was measured in study baseline and visit 3(12 week).

  3. Change in weight

    Time frame: Baseline and 12 week

    Weight was measured in study baseline and visit 3(12 week).

  4. Change in body mass index

    Time frame: Baseline and 12 week

    Body mass index was measured in study baseline and visit 3(12 week).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 16, 2014
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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