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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes; Newly Diagnosed Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: jerusalem artichoke and fermented soybeans powder mixture; Dietary supplement: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; jerusalem artichoke and fermented soybeans powder mixture supplementation	Dietary supplement: jerusalem artichoke and fermented soybeans powder mixture; 40 g jerusalem artichoke and fermented soybean powder mixture
Placebo Comparator: Placebo group; placebo supplementation	Dietary supplement: placebo; 40 g powdered rice flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)	12 week

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Study Chair: Jong Ho Lee, PhD, Yonsei University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: AS_DM