The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control

Prediabetes Clinical Trial

Official title:

The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506582
• Other study ID #: AS_DM
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: July 22, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized, double-blind, placebo-controlled study was to determine whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.

Description:

The objective of this clinical study was to evaluate the effect of jerusalem artichoke and fermented soybean powder mixture supplementation on blood glucose. A randomized, double-blinded, placebo-controlled study was conducted on 60 subjects with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes. The subjects were randomly assigned to either a group ingesting 40 g jerusalem artichoke and fermented soybean powder mixture supplementation daily or a placebo group for 12-week. We assessed fasting and postprandial levels of glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. All subjects were with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose =126 mg/dL or 2-h OGTTs level = 200 mg/dL.

Exclusion Criteria:

1. glucose lowering medications or insulin injections;

2. abnormal liver or renal function;

3. chronic stomach and intestines disease;

4. chronic alcoholism;

5. pregnancy or intending to become pregnant during time of study.

6. complications;

7. an occupation that could be dangerous if hypoglycemia should occur.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Newly Diagnosed Type 2 Diabetes
• Prediabetes

Intervention

Dietary Supplement:
• jerusalem artichoke and fermented soybeans powder mixture
40 g jerusalem artichoke and fermented soybean powder mixture
• placebo
40 g powdered rice flour

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)		12 week	Yes