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

Primary Purpose

Prediabetes, Newly Diagnosed Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

jerusalem artichoke and fermented soybeans powder mixture

placebo

About this trial

This is an interventional treatment trial for Prediabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

glucose lowering medications or insulin injections;
abnormal liver or renal function;
chronic stomach and intestines disease;
chronic alcoholism;
pregnancy or intending to become pregnant during time of study.
complications;
an occupation that could be dangerous if hypoglycemia should occur.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Placebo group

Arm Description

jerusalem artichoke and fermented soybeans powder mixture supplementation

placebo supplementation

Outcomes

Primary Outcome Measures

Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)

Secondary Outcome Measures

Full Information

NCT ID

NCT02506582

First Posted

May 6, 2015

Last Updated

July 22, 2015

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02506582

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes, Newly Diagnosed Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

jerusalem artichoke and fermented soybeans powder mixture supplementation

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

placebo supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

jerusalem artichoke and fermented soybeans powder mixture

Intervention Description

40 g jerusalem artichoke and fermented soybean powder mixture

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

40 g powdered rice flour

Primary Outcome Measure Information:

Title

Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)

Time Frame

12 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: glucose lowering medications or insulin injections; abnormal liver or renal function; chronic stomach and intestines disease; chronic alcoholism; pregnancy or intending to become pregnant during time of study. complications; an occupation that could be dangerous if hypoglycemia should occur.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Ho Lee, PhD

Organizational Affiliation

Yonsei University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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