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

NCT02140697 | Completed Phase 2 DMC

• 1 other identifier: SS-BF-HLE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in body fat mass

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

  Baseline and 12 week

Secondary Outcomes (4)

• Change in percent body fat

  Baseline and 12 week

• Change in fat free mass

  Baseline and 12 week

• Change in weight

  Baseline and 12 week

• Change in body mass index

  Baseline and 12 week

Study Arms (2)

Hippophae rhamnoides L. Leaf Extract

EXPERIMENTAL

Hippophae rhamnoides L. Leaf Extract 3g/day

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

Placebo

PLACEBO COMPARATOR

Placebo 3g/day

Dietary Supplement: Placebo (3g/day)

Interventions

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

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

Hippophae rhamnoides L. Leaf Extract

Placebo (3g/day) DIETARY_SUPPLEMENT

Placebo (3g/day), parallel design

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 19 and 65 years,
• BMI 25\~29.9 kg/m2 or Waist circumference ≥ 90(men), ≥ 85(women),
• subjects giving written informed consent

You may not qualify if:

• 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,.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Chonbuk National University Hospital

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

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

KR (1)