Efficacy and Safety of Red Ginseng on Decrement of Body Fat

NCT01734005 | Completed DMC

• 1 other identifier: ARIMED-BF-GC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Changes in Body Fat Mass

  Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).

  12 weeks

• Changes in Percent Body Fat

  Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).

  12 weeks

Secondary Outcomes (2)

• Changes in weight

  12 weeks

• Changes in BMI(body mass index)

  12 weeks

Study Arms (2)

Red Ginseng

EXPERIMENTAL

Dietary Supplement: Red Ginseng

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Red Ginseng DIETARY_SUPPLEMENT

Red Ginseng (1.4g/day)

Red Ginseng

Placebo DIETARY_SUPPLEMENT

Placebo (1.4g/day)

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:

• Males and females 19-65 years old
• BMI(body mass index) ≥ 25 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
• Able to give informed consent

You may not qualify if:

• Significant variation in weight(more 10%) in the past 3 months
• Allergic or hypersensitive to any of the ingredients in the test products
• History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
• History of alcohol or substance abuse
• 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
• Pregnant or lactating women etc.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Obesity

Interventions

Asian ginseng

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: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: October 10, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

KR (1)